CDE Detailed Report

Disease: Parkinson's Disease
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
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
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
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

Free-Form Entry
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
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

Free-Form Entry
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
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
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
CSV