CDE Detailed Report

Disease: Parkinson's Disease
Sub-Domain: Surgeries and Other Procedures
CRF: Functional Neurosurgery

Displaying 51 - 79 of 79
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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C08072 Surgical complication intracranial anatomic site SurgComplicIntracranAntmicSte Anatomic site of the surgical complication, if intracranial Anatomic site of the surgical complication, if intracranial Location of complication if intracranial Alphanumeric

Only answer if surgical complication is intracranial, otherwise leave blank. 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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery 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;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

0 99
C08051 Stimulation parameters brain hemisphere type StimParamBrainHemisphTyp Side of the brain targeted for stimulation Side of the brain targeted for stimulation Left Brain Right Brain Right;Left Right Brain;Left Brain Alphanumeric

Choose all that apply

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C18750 Risk Factor Questionnaire (RFQ) - significant injury surgery anesthesia administered other text RFQSignfcntInjSxAnesthAdmOTH The free-text field related to 'Risk Factor Questionnaire (RFQ) - significant injury surgery anesthesia administered type' specifying other text. Type of anesthesia given to participant/subject as part of the Risk Factor Questionnaire (RFQ). The free-text field related to 'Risk Factor Questionnaire (RFQ) - significant injury surgery anesthesia administered type' specifying other text. Type of anesthesia given to participant/subject as part of the Risk Factor Questionnaire (RFQ). Other, specify Alphanumeric

Choose only one

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08030 Anterior commissure posterior commissure target coordinate value ACPCTrgtCoordVal Stereotactic coordinates with respect to anterior and posterior commissure (brain nuclei) Stereotactic coordinates with respect to anterior and posterior commissure (brain nuclei) AC PC target coordinates Alphanumeric

Specify left and right coordinates if procedure is unilateral

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 255

Free-Form Entry

C08062 Extenders replaced number ExtndrReplacNum Number of extenders replaced Number of extenders replaced Extender number replaced Numeric Values

Only answer if 'Extender' is answered for 'Hardware replacements'

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08073 Adverse event relatedness source AdvrsEvntRelatSrc What the adverse event or complication was likely related to or caused by What the adverse event or complication was likely related to or caused by Complication related to Surgery;Device;Other, specify Surgery;Device;Other, specify Alphanumeric

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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C08019 Disease duration DiseasDurat Duration of disease at time of surgery Duration of disease at time of surgery Disease Duration at Time of Surgery Numeric Values

This value should be captured in months and/or years.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C08052 Stimulation brain parameters amplitude range StimBrainParamAmpRng Amplitude of electric pulses (stimulation) on brain hemisphere Amplitude of electric pulses (stimulation) on brain hemisphere Amplitude Range: Volts Numeric Values

This value should be answered in Volts. Answer for both left brain and right brain.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

Volt
C18755 Stereotactic surgery frame other text StereostatSurgFrmOTH The free-text field related to 'Stereotactic surgery frame type' specifying other text. Scaffold or support used for stereotactic surgery The free-text field related to 'Stereotactic surgery frame type' specifying other text. Scaffold or support used for stereotactic surgery Other, specify Alphanumeric

CRW (manufactured by Radionics) and Leksell (manufactured by Elekta) are the two most common frame types.

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

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;Indirect;Atlas;Planning Platform;Imaging;Ventriculography;Other, specify Direct;Indirect;Atlas;Planning Platform;Imaging;Ventriculography;Other, 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 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C08063 Lead repositioned indicator LeadRepositInd Indicator of whether a lead was repositioned in the participant/subject Indicator of whether a lead was repositioned in the participant/subject Was lead repositioned in patient Yes;No;Unknown Yes;No;Unknown Alphanumeric

If N/A is answered, skip to Q#8 (Surgical complications)

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08042 Surgery externalization use indicator SurgExtrnlUseInd A procedure of exposing the implanted electrodes out of the brain for stimulation purposes A procedure of exposing the implanted electrodes out of the brain for stimulation purposes Use of Externalization Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose only one

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08074 Adverse event relatedness source device type AdvrsEvntRelatSrcDevTyp If the adverse event or complication was likely related to or caused by a device, the type of device involved If the adverse event or complication was likely related to or caused by a device, the type of device involved Complication related to Device Electrode;IPG Electrode;IPG Alphanumeric

Answered only if Device is answered for previous question. 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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08020 Surgery reason indication type SurgRsnIndTyp Reason participant/subject is in need of surgery Reason participant/subject is in need of surgery Indication(s) for Surgery Tremors;Dyskinesias;Motor fluctuations;Drug/medication side effects;Trauma;Tracheostomy;Cardiomyopathy/Arrhythmia/Cardiac Device Implantation;Other, specify Tremors;Dyskinesias;Motor fluctuations;Drug/medication side effects;Trauma;Tracheostomy;Cardiomyopathy/Arrhythmia/Cardiac Device Implantation;Other, specify Alphanumeric

Select only one.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08053 Stimulation brain parameters frequency range StimBrainParamFreqRng Frequency (Hz) of electric pulses (stimulation) on brain hemisphere Frequency (Hz) of electric pulses (stimulation) on brain hemisphere Frequency Range: Hz Numeric Values

This value should be answered in Hertz (Hz) Answer for both left brain and right brain.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

Hertz
C18757 Surgery lead secure method other text SurgLeadSecurMethdOTH The free-text field related to 'Surgery lead secure method type' specifying other text. 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 Field related to 'Surgery lead secure method type' specifying other text. 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 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;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08032 Risk Factor Questionnaire (RFQ) - significant injury surgery anesthesia administered type RFQSignfcntInjSxAnesthAdmType Type of anesthesia given to participant/subject as part of the Risk Factor Questionnaire (RFQ). Type of anesthesia given to participant/subject as part of the Risk Factor Questionnaire (RFQ). Type of Anesthesia General;Local;Other, specify;Spinal block General;Local;Other, specify;Spinal block Alphanumeric

Choose only one

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08064 Lead repositioned reason LeadRepositRsn Reason the lead was repositioned in the participant/subject Reason the lead was repositioned in the participant/subject If yes please select reason lead repositioned Poor positioning;Mechanical breakdown;Infection;Other, specify Poor positioning;Mechanical breakdown;Infection;Other, specify Alphanumeric

Choose only one.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08043 Lead implanted pulse generator model type LeadIPGMdlTyp Type of lead electrodes or implanted pulse generators used on the participant/subject for surgery Type of lead electrodes or implanted pulse generators used on the participant/subject for surgery Lead and IPG Modes Used Lead 3387;Lead 3389;IPG Soletra;IPG Kinetra;IPG Activa PC;IPG Activa RC;Medtronic;Other, specify Lead 3387;Lead 3389;IPG Soletra;IPG Kinetra;IPG Activa PC;IPG Activa RC;Medtronic;Other, specify Alphanumeric

Using the options listed, or free text, please specify the type of lead electrodes or implanted pulse generators used on the participant/subject for surgery

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C08075 Adverse event expected status AdvrsEvntExpecStatus Whether the adverse event or complication was expected or unexpected Whether the adverse event or complication was expected or unexpected Was complication expected? Expected;Unexpected Expected;Unexpected Alphanumeric

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;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08021 Surgery indication drug or medication side effects type SurgIndicDrgMedSdEffctTyp Type of drug or medication side effects experienced by the participant/subject Type of drug or medication side effects experienced by the participant/subject Drug Medication Side Effects Insomnolence;Behavioral effects;Nausea/vomiting Insomnolence;Behavioral effects;Nausea/vomiting Alphanumeric

Only answer if "Drug/Medication side effects" is answered for 'Indication(s) for surgery'

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08054 Stimulation brain parameters pulse width range StimBrainParamPlsWdthRng Width of electric pulses (stimulation) on brain hemisphere Width of electric pulses (stimulation) on brain hemisphere Pulse Width Range: microsec Numeric Values

This value should be answered in microseconds (?sec) Answer for both left brain and right brain.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

microsecond
C18758 Surgery post-operative target verification method other text SurgPstOpTrgtVerifMethdOTH The free-text field related to 'Surgery post-operative target verification method source' specifying other text. Post-operative source method used for verifying the brain nucleus (target) was reached The free-text field related to 'Surgery post-operative target verification method source' specifying other text. Post-operative source method used for verifying the brain nucleus (target) was reached Other, specify Alphanumeric

Using the options listed, or free text, please specify the method used for post-operative target verification

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

C08033 Medication anti-Parkinsonian during procedure indicator MedAntiPrknsnDurngProcInd Indicator of whether the participant/subject was on anti-Parkinsonian medication(s) during the surgical procedure Indicator of whether the participant/subject was on anti-Parkinsonian medication(s) during the surgical procedure Was patient on anti-Parinsonian Medication(s) during Procedure Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose only one

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08065 Surgical complications category SurgComplicCat Category of the surgical complication experienced by the participant/subject Category of the surgical complication experienced by the participant/subject Surgical Complications Intra-Operative;Post-Operative;N/A Intra-Operative;Post-Operative;N/A Alphanumeric

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.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Single Pre-Defined Value Selected

C08044 Operating room total time OpRmTtlTm Participant's/subject's total time in the operating room Participant's/subject's total time in the operating room Total Time in the Operating Room Numeric Values

This value should be collected in hours and minutes.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data

Free-Form Entry

C18662 Aborted procedures other text AbrtProcOTH The free-text field related to 'Aborted procedures reason' specifying other text. Reason for aborted procedures The free-text field related to 'Aborted procedures reason' specifying other text. Reason for aborted procedures Other, specify Alphanumeric

Only answer if 'Yes' is answered for 'Aborted procedures'. '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;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Functional Neurosurgery Surgeries and Other Procedures Treatment/Intervention Data 4000

Free-Form Entry

CSV