CDE Detailed Report

Disease: system
Subdomain Name: Surgeries and Other Procedures
CRF: files

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
C59108 Stereotactic surgery robotic guidance lead insert indicator StereotactSrgRbtcGdncLdInstInd Indicator of whether robotic guidance was used during stereotactic surgery for lead insertion Indicator of whether robotic guidance was used during stereotactic surgery for lead insertion Robotic guidance No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 09:45:41.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C59145 Brain lead post implant interval unit of measure BrainLeadPostImplantIntrvlUOM Unit of measure for the interval post implantation of brain leads at which the stimulation and parameters and clinical motor outcomes were documented Unit of measure for the interval post implantation of brain leads at which the stimulation and parameters and clinical motor outcomes were documented Number of weeks/months post implantation that these stimulation and parameters and clinical motor outcomes were documented Week;Month Week;Month Alphanumeric

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 10:58:39.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08065 Surgical complication category SurgComplicCat Category of the surgical complication experienced by the participant/subject Category of the surgical complication experienced by the participant/subject Complications not directly involving hardware Intra-Operative;Post-Operative;N/A Intra-Operative;Post-Operative;N/A Alphanumeric

Within 3 months of implantation.
In order to prevent duplication of data collection, the General Adverse Event form will be considered Core for clinical trials. If the information on that form does not completely capture what is needed, the surgical complications section can be supplemental.
If N/A, go to question on hardware-related complications

No references available Adult Supplemental 3.10 2022-07-29 11:48:19.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C59123 Brain lead intercontact space interval type other text BrainLdIntcntctSpcIntrvlTypOTH The free-text field related to 'Brain lead intercontact space interval type', specifying other text. Type of intercontact spacing interval for the implanted brain leads (between ends of contacts, not centers) The free-text field related to 'Brain lead intercontact space interval type', specifying other text. Type of intercontact spacing interval for the implanted brain leads (between ends of contacts, not centers) Other, specify Alphanumeric

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 10:24:02.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08017 Case report number CaseRprtNum Although not a data item, the case report number may be helpful for centers to track and enumerate the number of PD DBS surgeries performed Although not a data item, the case report number may be helpful for centers to track and enumerate the number of PD DBS surgeries performed Case report Alphanumeric

If known, please give the case report number

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 255

Free-Form Entry

C59156 Pulse generator replacement reason PulseGeneratorRplcmntRsn The reason the pulse generator was replaced The reason the pulse generator was replaced Select reason for pulse generator replacement Electrical malfunction;Rechargeable pulse generator flipped over and cannot be recharged;Discomfort;Other, specify Electrical malfunction;Rechargeable pulse generator flipped over and cannot be recharged;Discomfort;Other, specify Alphanumeric

For reason other than infection

No references available Adult Supplemental 1.00 2022-07-28 11:22:59.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C18761 Surgical complication intra-operative type other text SurgComplicIntraOpTypOTH The free-text field related to 'Surgical complications intra-operative type', specifying other text. Type of intra-operative surgical complications experienced by the participant/subject The free-text field related to 'Surgical complications intra-operative type', specifying other text. Type of intra-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 11:49:54.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 4000

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C59095 L-Dopa pre-operative challenge off levodopa duration LDopaPreOpChllngOffLevodopaDur Duration in hours the participant/subject was off of levodopa as part of the pre-operative L-Dopa challenge Duration in hours the participant/subject was off of levodopa as part of the pre-operative L-Dopa challenge Hours of off levodopa Numeric Values

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 09:31:52.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

hour
C59134 Stimulation brain parameter amplitude unit of measure StimBrainParamAmpUOM Unit of measure for amplitude of electric impulses (stimulation) on brain hemisphere Unit of measure for amplitude of electric impulses (stimulation) on brain hemisphere Amplitude mA;Volts milliampere;Volts Alphanumeric

Answer for both left brain and right brain if applicable

No references available Adult Supplemental 1.00 2022-07-28 10:34:49.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08038 Surgery intra-operative target verification source SurgIntraOpTrgtVerifSource Intra-operative source method used for verifying the target of the surgery Intra-operative source method used for verifying the target of the surgery Intra-operative target verification Fluoroscopy;CT or cone beam CT;Microelectrode recording and/or microstimulation;Test stimulation through DBS lead or other microcontact;MRI Fluoroscopy;CT or cone beam CT;Microelectrode recording and/or microstimulation;Test stimulation through DBS lead or other microcontact;MRI Alphanumeric

Check all that apply

No references available Adult Supplemental 4.00 2022-07-29 17:45:23.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C59589 Anterior commissure posterior commissure target y coordinate value ACPCTrgtYCoordVal Stereotactic y coordinate with respect to anterior and posterior commissure (brain nuclei) Stereotactic y 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) y 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

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C59109 Stereotactic surgery robotic guidance lead insert platform text StertctSrgRbtGdnLdInstPlfmTxt The free-text field related to the robotic guidance platform used during stereotactic surgery for lead insertion The free-text field related to the robotic guidance platform used during stereotactic surgery for lead insertion If yes, specify platform Alphanumeric

No instructions available

No references available Adult Supplemental 1.00 2022-07-28 09:47:04.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 255

Free-Form Entry

C59146 Surgical complication hemorrhage symptom status SurgComplicHemorrhgSymptmStat Status of hemorrhage symptoms related to intra-operative or post-operative surgical complications Status of hemorrhage symptoms related to intra-operative or post-operative surgical complications Hemorrhage If yes Symptomatic;Asymptomatic Symptomatic;Asymptomatic Alphanumeric

Answer if 'Hemorrhage' is selected as an intra-operative or post-operative surgical complication type

No references available Adult Supplemental 1.00 2022-07-28 11:03:13.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08066 Surgical complication intra-operative type SurgComplicIntraOpTyp Type of intra-operative surgical complications experienced by the participant/subject Type of intra-operative surgical complications experienced by the participant/subject Intra-operative Hemorrhage;Seizure;Change of mental status;Other, specify;Cardiovascular event (e.g., arrhythmia, heart attack, etc.);Procedure aborted Hemorrhage;Seizure;Change of mental status;Other, specify;Cardiovascular event (e.g., arrhythmia, heart attack, etc.);Procedure aborted 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 11:48:51.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

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

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

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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

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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
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

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

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

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

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

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

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

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

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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

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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

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

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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

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

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

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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

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

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

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

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

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

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

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

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

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

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

CSV