CDE Detailed Report
Disease: Parkinson's Disease
Subdomain Name: Surgeries and Other Procedures
CRF: Functional Neurosurgery: Deep Brain Stimulation
Displaying 101 - 114 of 114
Subdomain Name: Surgeries and Other Procedures
CRF: Functional Neurosurgery: Deep Brain Stimulation
Displaying 101 - 114 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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| 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 |
Free-Form Entry |
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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 | |||||||||
| 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 |
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| 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 |
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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 |
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| 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 |
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