CDE Detailed Report

Disease: content
Subdomain Name: Surgeries and Other Procedures
CRF: welcome

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
C59155 Pulse generator replacement manipulation count PulseGeneratorRplcmntMnpltnCt Count of pulse generators replaced or manipulated Count of pulse generators replaced or manipulated If yes, how many Numeric Values

For reason other than infection

 No references available Adult Supplemental 1.00 2022-07-28 11:22:07.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry
C18760 Surgery skull opening type other text SurgSkulOpngTypOTH The free-text field related to 'Surgery skull opening type', specifying other text. Type of drilling or perforation of the skull in order to get access to the brain The free-text field related to 'Surgery skull opening type', specifying other text. Type of drilling or perforation of the skull in order to get access to the brain Other, specify Alphanumeric

Using the options listed, or free text, please specify the type of drilling or perforation of the skull in order to get access to the brain

 No references available Adult Supplemental 1.10 2022-07-29 11:44:35.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data 4000

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C59122 Brain lead intercontact space interval type BrainLdIntcntctSpcIntrvlTyp Type of intercontact spacing interval for the implanted brain leads (between ends of contacts, not centers) Type of intercontact spacing interval for the implanted brain leads (between ends of contacts, not centers) Intercontact spacing (between ends of contacts, not centers) 0.5 mm;1.5 mm;3 mm;Other, specify 0.5 mm;1.5 mm;3 mm;Other, specify Alphanumeric

No instructions available

 No references available Adult Supplemental 1.00 2022-07-28 10:21:25.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected
C59133 Stimulation brain parameter amplitude value StimBrainParamAmpVal Value of the amplitude of electric pulses (stimulation) on brain hemisphere Value of the amplitude of electric pulses (stimulation) on brain hemisphere Amplitude Numeric Values

This value should be answered in Volts or milliampere (mA). Answer for both left brain and right brain if applicable

 No references available Adult Supplemental 1.00 2022-07-28 10:34:09.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

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C08037 Surgery skull opening type SurgSkulOpngTyp Type of drilling or perforation of the skull in order to get access to the brain Type of drilling or perforation of the skull in order to get access to the brain Type of Opening Burr hole;Twist drill hole;Other, specify Burr hole;Twist drill hole;Other, specify Alphanumeric

Using the options listed, or free text, please specify the type of drilling or perforation of the skull in order to get access to the brain

 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
C59588 Anterior commissure posterior commissure target x coordinate value ACPCTrgtXCoordVal Stereotactic x coordinate with respect to anterior and posterior commissure (brain nuclei) Stereotactic x 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) x 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
C59094 Unified Parkinsons Disease Rating Scale part three off levodopa score UPDRSPartThreeOffLevodopaScore The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is off of levodopa The score related to part three of the Unified Parkinson's Disease Rating Scale (UPDRS) when the participant/subject is off of levodopa UPDRS part 3 score, off levodopa Numeric Values

No instructions available

 No references available Adult Supplemental 1.00 2022-07-28 09:30:49.0 Functional Neurosurgery: Deep Brain Stimulation Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry
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
CSV