CDE Detailed Report
Disease: content
Subdomain Name: Surgeries and Other Procedures
CRF: welcome
Displaying 1 - 50 of 114
Subdomain Name: Surgeries and Other Procedures
CRF: welcome
Displaying 1 - 50 of 114
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C59124 | Device model name | DevModelName | The name of the model of the device | The name of the model of the device | Lead model | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:25:17.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C08018 | Surgery age value | SurgAgeVal | Age of the participant/subject at the time of the selected surgical procedure | Age of the participant/subject at the time of the selected surgical procedure | Age at time of surgery | Numeric Values |
This element is not considered Core. Please refer to the Date of Birth element on the General Demographics form to derive age. If age is necessary to capture on this form, it may be added. |
No references available | Adult | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
0 | 99 | ||||||||
| C59158 | Pulse generator replacement reason other text | PulseGeneratorRplcmntRsnOTH | The free-text field related to 'Pulse generator replacement reason', specifying other text. The reason the pulse generator was replaced during further surgery | The free-text field related to 'Pulse generator replacement reason', specifying other text. The reason the pulse generator was replaced during further surgery | Other, specify | Alphanumeric |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:27:19.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C18763 | Surgical complication post-operative type other text | SurgComplicPstOpTypOTH | The free-text field related to 'Surgical complications post-operative type', specifying other text. Type of post-operative surgical complications experienced by the participant/subject | The free-text field related to 'Surgical complications post-operative type', specifying other text. Type of post-operative surgical complications experienced by the participant/subject | Other, specify | Alphanumeric |
Within 3 months of implantation. Choose only one. Please refer to the General Adverse Event (AE) form for details on reporting surgical complications. The General Adverse Event form should be considered core for clinical trials. If any additional details on the surgical complication are necessary to captured, this form may be used. |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:52:18.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59135 | Stimulation brain parameter frequency value | StimBrainParamFreqVal | Value of the frequency (Hz) of electric pulses (stimulation) on brain hemisphere | Value of the frequency (Hz) of electric pulses (stimulation) on brain hemisphere | Frequency: Hz | Numeric Values |
This value should be answered in Hertz (Hz). Answer for both left brain and right brain, if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:37:09.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
hertz | |||||||||
| C08039 | Electrode brain count | ElectrdBrainCt | Count of electrodes introduced in the brain | Count of electrodes introduced in the brain | Number of microelectrodes passed simultaneously | Numeric Values |
Only answer if 'Simultaneous multiple-microelectrode recording' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 4.00 | 2017-04-12 00:00:00.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
0 | 99 | ||||||||
| C59590 | Anterior commissure posterior commissure target z coordinate value | ACPCTrgtZCoordVal | Stereotactic z coordinate with respect to anterior and posterior commissure (brain nuclei) | Stereotactic z coordinate with respect to anterior and posterior commissure (brain nuclei) | AC-PC coordinates for lead tip with respect to midcommissural point (positive values are right, anterior, and superior, negative values are left, posterior, and inferior) z | Numeric Values |
Specify left and right coordinates if procedure is unilateral. Positive values are right, anterior, and superior, negative values are left, posterior, and inferior |
No references available | Adult | Supplemental | 1.00 | 2022-08-18 17:03:51.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C59096 | L-Dopa pre-operative challenge off dopamine agonist duration | LDopaPreOpChllngOffDpmAgnstDur | Duration in hours the participant/subject was off of dopamine agonists as part of the pre-operative L-Dopa challenge | Duration in hours the participant/subject was off of dopamine agonists as part of the pre-operative L-Dopa challenge | Hours of off dopamine agonists | Numeric Values |
Specify which agonists |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:32:41.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
hour | |||||||||
| C59110 | Surgery intra-operative target verify lead placement MRI type | SurgIntraOpTrgtVrfLdPlcmMRITyp | Type of magnetic resonance imaging (MRI) intra-operative target verification in relation to time of lead placement surgery | Type of magnetic resonance imaging (MRI) intra-operative target verification in relation to time of lead placement surgery | MRI | In surgical suite immediately following lead placement;Real time during placement | In surgical suite immediately following lead placement;Real time during placement | Alphanumeric |
Only answer if 'MRI' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:47:46.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59147 | Adverse event treatment specify text | AdvEvntTreatmtSpecifyTxt | The free-text field to specify the treatment required for the adverse event other than action taken with study intervention/ treatment | The free-text field to specify the treatment required for the adverse event other than action taken with study intervention/ treatment | Treatment required, specify | Alphanumeric |
If treatment was required, then the corresponding treatment needs to be recorded on the Prior and Concomitant Medications CRF |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:06:04.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C08067 | Surgical complication post-operative type | SurgComplicPstOpTyp | Type of post-operative surgical complications experienced by the participant/subject | Type of post-operative surgical complications experienced by the participant/subject | Post-operative | Hemorrhage;Seizure;Other, specify;Ischemic infarct;Delirium | Hemorrhage;Seizure;Other, specify;Ischemic infarct;Delirium | Alphanumeric |
Within 3 months of implantation. Choose only one. Please refer to the General Adverse Event (AE) form for details on reporting surgical complications. The General Adverse Event form should be considered core for clinical trials. If any additional details on the surgical complication are necessary to captured, this form may be used. |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 11:50:23.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59125 | Pulse generator insert count | PulseGeneratorInsertCt | Count of pulse generators inserted | Count of pulse generators inserted | Number of pulse generators inserted | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:25:58.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C08022 | Imaging magnetic resonance imaging findings result status | ImgMRIFndngResltStat | Results from MRI studies | Results from MRI studies indicator | MRI findings | Abnormal;Normal | Abnormal;Normal | Alphanumeric |
Choose only one |
No references available | Adult | Supplemental | 4.00 | 2022-07-29 11:39:59.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59159 | Lead extender replacement manipulation count | LeadExtndrRplcmntMnpltnCt | Count of brain lead extenders replaced or manipulated during further surgery | Count of brain lead extenders replaced or manipulated during further surgery | Other, specify | Numeric Values |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:28:03.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C54898 | Surgery procedure minute duration | SurgeryProcedureMinuteDur | Duration in minutes of surgery or procedure | Duration in minutes of surgery or procedure | Total surgical time (incision to closure): minutes | Numeric Values |
Time from incision to closure reported in minutes |
No references available | Adult | Supplemental | 1.10 | 2022-08-18 17:01:53.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
minute | |||||||||
| C59097 | Dopamine agonist specify text | DopamineAgonistSpecifyTxt | The free-text field to specify the dopamine agonist taken by the participant/subject | The free-text field to specify the dopamine agonist taken by the participant/subject | Specify which agonists | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:33:09.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C59136 | Stimulation brain parameter pulse width value | StimBrainParamPlsWdthVal | Value of the width of electric pulses (stimulation) on brain hemisphere | Value of the width of electric pulses (stimulation) on brain hemisphere | Pulse Width: microsec | Numeric Values |
This value should be answered in microseconds (?sec). Answer for both left brain and right brain, if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:38:17.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
microseconds | |||||||||
| C08040 | Microelectrode pass count | MicrelectrdPssCt | Count of times the microelectrode is passed through the brain | Count of times the microelectrode is passed through the brain | Number of electrode penetrations | Numeric Values |
Only answer if 'Serial single microelectrode recording' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 4.00 | 2022-07-29 11:45:30.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C59111 | Microelectrode record microstimulation sedation type | MicrlctrdRecMicrstimltnSedTyp | Type of sedation used during microelectrode recording or microstimulation for intra-operative target verification | Type of sedation used during microelectrode recording or microstimulation for intra-operative target verification | Microelectrode recording and/or microstimulation | No sedation;Light sedation;Gen anesthesia | No sedation;Light sedation;Gen anesthesia | Alphanumeric |
Only answer if 'Microelectrode recording and/or microstimulation' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:49:39.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59148 | Adverse event outcome status other text | AdvrsEvntOutcomStatusOTH | The free-text field related to 'Adverse event outcome status', specifying other text. Final status of the participant/subject related to the adverse event | The free-text field related to 'Adverse event outcome status', specifying other text. Final status of the participant/subject related to the adverse event | Other | Alphanumeric |
Complication outcome (at three months) |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:06:42.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C14517 | Device manufacturer name | DevManufName | The company responsible for development of the device | The name of the manufacturer of the device that was placed in the subject's body | Lead manufacturer | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C59126 | Pulse generator battery type | PulseGeneratorBatteryTyp | Type of battery used in the pulse generator(s) inserted | Type of battery used in the pulse generator(s) inserted | Number of pulse generators inserted | Rechargeable;Primary cell | Rechargeable;Primary cell | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:26:46.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C08023 | Imaging abnormal finding text | ImgAbnrmlFindTxt | Text description of the abnormal findings on the imaging study | Text description of the abnormal findings on the imaging study | If Abnormal, comment | Alphanumeric |
Only answered if 'Abnormal' is answered for the previous question |
No references available | Adult | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C59160 | Lead extender replacement reason | LeadExtndrRplcmntRsn | The reason the lead extender was replaced | The reason the lead extender was replaced | Select reason for lead extender replacement | Electrical malfunction;Discomfort;Other, specify | Electrical malfunction;Discomfort;Other, specify | Alphanumeric |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:28:37.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59085 | Parkinsons disease motor sign year duration | ParkinsonsDiseaseMotorSgnYrDur | Duration in years of motor signs related to Parkinson's disease at the time of surgery | Duration in years of motor signs related to Parkinson's disease at the time of surgery | Duration of motor signs of Parkinson's disease: years | Numeric Values |
This value should be captured in years |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:06:59.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
year | |||||||||
| C59099 | Unified Parkinsons Disease Rating Scale part three on medication score | UPDRSPartThreeOnMedctnScore | The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on medications | The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is on medications | UPDRS part 3 score, on medications | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:33:54.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C59137 | Stimulation brain paradigm type | StimBrainParadigmTyp | Type of brain stimulation paradigm | Type of brain stimulation paradigm | Stimulation paradigms, specify | Constant stimulation;Adaptive DBS;Coordinated reset;Other, specify | Constant stimulation;Adaptive DBS;Coordinated reset;Other, specify | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:39:04.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C08041 | Surgery lead secure method type | SurgLeadSecurMethdTyp | Type of method or device used to protect and secure the lead (part of the electrode that is introduced into the brain), this part must be safely secured and held still in position | Type of method or device used to protect and secure the lead (part of the electrode that is introduced into the brain), this part must be safely secured and held still in position | Method to secure lead | Mini-plate;Manufacturer's specific locking device;Other, specify | Mini-plate;Manufacturer's specific locking device;Other, specify | Alphanumeric |
Using the options listed, or free text, please specify the type of method or device used to protect and secure the lead (part of the electrode that is introduced into the brain), this part must be safely secured and held still in position |
No references available | Adult | Supplemental | 3.00 | 2013-07-22 09:34:41.527 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59113 | Microelectrode record type | MicroelectrdRecTyp | Type of microelectrode recording done for intra-operative target verification | Type of microelectrode recording done for intra-operative target verification | Microelectrode recording and/or microstimulation | Serial single microelectrode recording;Simultaneous multiple-microelectrode recording | Serial single microelectrode recording;Simultaneous multiple-microelectrode recording | Alphanumeric |
Only answer if 'Microelectrode recording and/or microstimulation' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:57:43.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59149 | Surgical complication hardware related type | SurgComplicHrdwrRelatedTyp | Type of hardware related surgical complication experienced by the participant/subject | Type of hardware related surgical complication experienced by the participant/subject | Hardware-related complications | Further surgery for replacement or manipulation of a brain lead (for reason other than infection);Further surgery for replacement or manipulation of lead extender (for reason other than infection);Further surgery for replacement or manipulation of pulse generator (for reason other than infection);Hardware infection requiring further surgery for removal of hardware components;N/A | Further surgery for replacement or manipulation of a brain lead (for reason other than infection);Further surgery for replacement or manipulation of lead extender (for reason other than infection);Further surgery for replacement or manipulation of pulse generator (for reason other than infection);Hardware infection requiring further surgery for removal of hardware components;N/A | Alphanumeric |
Within three months of implantation |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:07:37.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C18681 | Functional neurosurgery target anatomic site other text | FuncNeurosurgTrgtAnatSiteOTH | The free-text field related to 'Functional neurosurgery target anatomic site', specifying other text. The anatomic site in the brain nucleus or group of neurons to be intervened for surgery | The free-text field related to 'Functional neurosurgery target anatomic site', specifying other text. The anatomic site in the brain nucleus or group of neurons to be intervened for surgery | Other, specify | Alphanumeric |
Using the options listed, or free text, please specify the anatomic site in the brain nucleus or group of neurons to be intervened for surgery |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:41:32.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59127 | Pulse generator sensing function indicator | PulseGeneratorSnsngFunctionInd | Indicator of whether the pulse generator inserted has sensing function | Indicator of whether the pulse generator inserted has sensing function | Pulse generator has sensing function? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:28:59.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C08026 | Functional neurosurgery target anatomic site | FuncNeurosurgTrgtAnatSite | The anatomic site in the brain nucleus or group of neurons to be intervened for surgery | The anatomic site in the brain nucleus or group of neurons to be intervened for surgery | Structure targeted | Subthalamic Nucleus (STN);Other, specify;Ventrolateral thalamus;None;Multiple ipsilateral leads, specify;Globus Pallidus;Pedunculopontine nucleus (PPN) | Subthalamic Nucleus (STN);Other, specify;Ventrolateral thalamus;None;Multiple ipsilateral leads, specify;Globus Pallidus;Pedunculopontine nucleus (PPN) | Alphanumeric |
Using the options listed, or free text, please specify the anatomic site in the brain nucleus or group of neurons to be intervened for surgery |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 12:07:26.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59162 | Lead extender replacement reason other text | LeadExtndrRplcmntRsnOTH | The free-text field related to 'Lead extender replacement reason', specifying other text. The reason the lead extender was replaced | The free-text field related to 'Lead extender replacement reason', specifying other text. The reason the lead extender was replaced | Other, specify | Alphanumeric |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:30:28.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59086 | Motor fluctuation year duration | MotorFluctuationYrDur | Duration in years of motor fluctuations at the time of surgery | Duration in years of motor fluctuations at the time of surgery | Duration of motor fluctuations: years | Numeric Values |
Specify zero if none. This value should be captured in years |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:09:24.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
year | |||||||||
| C59100 | Functional neurosurgery target anatomic site multiple ipsilateral lead specify text | FnNsrgTgtAntSteMltIpltlLdSpTxt | The free-text field to specify the anatomic site targets when multiple ipsilateral leads are used in functional neurosurgery procedure | The free-text field to specify the anatomic site targets when multiple ipsilateral leads are used in functional neurosurgery procedure | Multiple ipsilateral leads, specify | Alphanumeric |
Using the options listed, or free text, please specify the anatomic site in the brain nucleus or group of neurons to be intervened for surgery |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:34:37.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C59138 | Stimulation brain paradigm type other text | StimBrainParadigmTypOTH | The free-text field related to 'Stimulation brain paradigm type', specifying other text. Type of brain stimulation paradigm | The free-text field related to 'Stimulation brain paradigm type', specifying other text. Type of brain stimulation paradigm | Other, specify | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:42:19.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C08042 | Surgery externalization use indicator | SurgExtrnlUseInd | Indicator of whether a procedure of exposing the implanted electrodes out of the brain for stimulation purposes was performed | Indicator of whether a procedure of exposing the implanted electrodes out of the brain for stimulation purposes was performed | Use of lead externalization | Yes;No | Yes;No | Alphanumeric |
Choose only one |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 12:17:15.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59115 | Test stimulation sedation type | TestStimulationSedationTyp | Type of sedation used during test stimulation through deep brain stimulation (DBS) lead or other microcontact used during intra-operative target verification | Type of sedation used during test stimulation through deep brain stimulation (DBS) lead or other microcontact used during intra-operative target verification | Test stimulation through DBS lead or other microcontact | No sedation;Light sedation;Gen anesthesia | No sedation;Light sedation;Gen anesthesia | Alphanumeric |
Only answer if 'Test stimulation through DBS lead or other microcontact' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:00:09.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59150 | Hardware component remove type | HrdwrCompRemoveTyp | Type of hardware component removed | Type of hardware component removed | Component removed | Brain lead;IPG;Lead extender | Brain lead;IPG;Lead extender | Alphanumeric |
Specify number of hardware components removed as applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:11:51.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
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| C18682 | Functional neurosurgery target planning method type other text | FuncNrsrgTrgtPlnngMethdTypOTH | The free-text field related to 'Functional neurosurgery target planning method type', specifying other text. The type of method used to determine the coordinates of the target (brain nucleus) | The free-text field related to 'Functional neurosurgery target planning method type', specifying other text. The type of method used to determine the coordinates of the target (brain nucleus) | Other targeting methods, specify | Alphanumeric |
Using the options listed, or free text, please specify the type of method used to determine the coordinates of the target (brain nucleus) |
No references available | Adult | Supplemental | 1.10 | 2022-07-29 11:42:56.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59128 | Imaging processing software name | ImgProcessSftwrName | Name of the software used for imaging processing | Name of the software used for imaging processing | Software utilized for image processing if any (for example LeadDBS, Brainlab Elements, etc.) | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:30:20.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C08031 | Functional neurosurgery target planning method type | FuncNeurosurgTrgtPlnngMethdTyp | The type of method used to determine the coordinates of the target (brain nucleus) | The type of method used to determine the coordinates of the target (brain nucleus) | Target planning method | Direct targeting on MRI;Indirect targeting on MRI;Indirect targeting on CT;Surgical planning software;Surgical planning adjuncts;Other targeting methods, specify | Direct targeting on MRI;Indirect targeting on MRI;Indirect targeting on CT;Surgical planning software;Surgical planning adjuncts;Other targeting methods, specify | Alphanumeric |
Check all that apply |
No references available | Adult | Supplemental | 3.00 | 2013-07-22 09:34:41.527 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
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| C59583 | Parkinsons disease motor sign month duration | ParkinsonsDiseaseMotorSgnMoDur | Duration in months of motor signs related to Parkinson's disease at the time of surgery | Duration in months of motor signs related to Parkinson's disease at the time of surgery | Duration of motor signs of Parkinson's disease: months | Numeric Values |
This value should be captured in months |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:06:59.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
month | |||||||||
| C59087 | Dyskinesia troublesome year duration | DyskinesiaTroublesomeYrDur | Duration in years of troublesome dyskinesias at the time of surgery | Duration in years of troublesome dyskinesias at the time of surgery | Duration of troublesome dyskinesias: years | Numeric Values |
Specify zero if none. This value should be captured in years |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:10:35.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
year | |||||||||
| C59101 | Functional neurosurgery target planning software type text | FuncNrsrgTrgtPlnngSftwrTypTxt | The free-text field to describe the type of functional neurosurgery target planning software used to determine the coordinates of the target (brain nucleus) | The free-text field to describe the type of functional neurosurgery target planning software used to determine the coordinates of the target (brain nucleus) | Surgical planning software type | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:35:13.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C59139 | Optimal programming limit stimulation adverse effect indicator | OptmlPrgmgLmtStmAdvrsEfctInd | Indicator related to whether optimal programming is limited by stimulation-induced adverse effects | Indicator related to whether optimal programming is limited by stimulation-induced adverse effects | Optimal programming limited by stimulation-induced adverse effects | Yes, specify;No | Yes, specify;No | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:43:19.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C08045 | Surgery post-operative target verification method source | SurgPstOpTrgtVerifMethdSource | Post-operative source method used for verifying the brain nucleus (target) was reached | Post-operative source method used for verifying the brain nucleus (target) was reached | Modality | CT;MRI;Other, specify | CT;MRI;Other, specify | Alphanumeric |
Using the options listed, or free text, please specify the method used for post-operative target verification |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 12:09:00.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
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| C59117 | Brain lead insert count | BrainLeadInsertCt | Count of brain leads inserted | Count of brain leads inserted | Number of brain leads inserted | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:14:11.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C02302 | Adverse event other action taken type | AdvEvntOthrActionTakenTyp | Type of action taken due to adverse event other than action taken with study intervention/ treatment | Type of action taken due to adverse event other than action taken with study intervention/ treatment | Action Taken | None;Treatment required, specify | None;Treatment required, specify | Alphanumeric |
Choose one. If treatment was required, then the corresponding treatment needs to be recorded on the Prior and Concomitant Medications CRF. |
No references available | Adult | Supplemental | 3.00 | 2013-07-22 09:34:41.527 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
3141322 |
