CDE Detailed Report | NINDS Common Data Elements

Disease: Epilepsy
Subdomain Name: Devices
CRF: Devices Log

Displaying 1 - 21 of 21

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
C14523	Device neurostimulator anatomic site	DevNeurostimAntmicSite	The location in the body of where the device is providing electrical stimulation	The location in the body of where the device is providing electrical stimulation	Location of Neurostimulator	Right chest;Left chest;Other, specify	Right chest;Left chest;Other, specify	Alphanumeric	Choose all that apply; if other specify. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data		Multiple Pre-Defined Values Selected
C18958	Device neurostimulator anatomic other text	DevNeurostimAntmicOTH	The free-text field related to 'Device neurostimulator anatomic site' specifying other text. The location in the body of where the device is providing electrical stimulation	The free-text field related to 'Device neurostimulator anatomic site' specifying other text. The location in the body of where the device is providing electrical stimulation	Other, specify			Alphanumeric	Choose all that apply; if other specify. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data	4000	Free-Form Entry
C14524	Device permanent explant date	DevPermExplantDate	Date the device was removed from the subject	Date the device was removed from the subject	Date of Permanent Explant			Date or Date & Time	As applicable, complete the Implanted Devices Log if (device) not explanted. Core for all prospective intervention studies. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data		Free-Form Entry
C18959	Device discontinuation other text	DevDisctOTH	The free-text field related to 'Device discontinuation reason' specifying other text. The reason the subject discontinued use of the device	The free-text field related to 'Device discontinuation reason' specifying other text. The reason the subject discontinued use of the device	Other, specify			Alphanumeric	Indicate reason for discontinuation, if applicable Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data	4000	Free-Form Entry
C14525	Device part left in the body indicator	DevPartLftInBodyInd	An indicator of whether any part of the device was left in the subject's body after the device was removed, with identification of the part	An indicator of whether any part of the device was left in the subject's body after the device was removed and identification of the part	Is any part of the device left in the body?	No;Yes	No;Yes	Alphanumeric	Indicate if any part of device is remaining in body after therapy. Record in the log along with the location of the part. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data		Single Pre-Defined Value Selected
C14515	Device implanted type	DevImpTyp	The type of device used	The type of device used	Device Name	VNS;DBS;RNS;Other, specify	VNS (Vagus Nerve Stimulation);DBS (Deep Brain Stimulation);RNS (Responsive Neurostimulation System);Other, specify	Alphanumeric	Record the type of device. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data		Single Pre-Defined Value Selected
C14527	Device discontinuation reason	DevDisctRsn	The reason the subject discontinued use of the device	The reason use of the device was discontinued	If applicable, Reason for Discontinuation	Serious device adverse effect(s), specify;Intolerable stimulation related adverse event, specify;Other adverse event, specify;Inadequate Seizure Control;Other, specify	Serious device adverse effect(s), specify;Intolerable stimulation related adverse event, specify;Other adverse event, specify;Inadequate Seizure Control;Other, specify	Alphanumeric	Indicate reason for discontinuation, if applicable Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data		Single Pre-Defined Value Selected
C14516	Device implanted implant date and time	DevImpImplantDateTime	Date (and time, if applicable and known) the device was implanted and became functional	Date (and time, if applicable and known) the device was implanted and became functiona	Date of Initial Implant			Date or Date & Time	Record the date of initial implant. Core for all prospective intervention studies. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data		Free-Form Entry
C18556	Device implanted intolerable stimulation adverse effect modification description text	DevImpIntoleStimAEModDescTxt	The reason for modification of original parameters or original electrode configuration of implanted device due to intolerable stimulation related Adverse Event (AE), specification	The reason for modification of original parameters or original electrode configuration of implanted device due to intolerable stimulation related Adverse Event (AE), specification	Intolerable Stimulation Related Adverse Event, specify			Alphanumeric		No references available	Adult;Pediatric	Supplemental	3.00	2013-07-30 14:29:49.047	Devices Log	Devices	Treatment/Intervention Data	255	Free-Form Entry
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	Device Manufacturer			Alphanumeric	Record the device manufacturer. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data	255	Free-Form Entry
C18558	Device implanted other adverse effect modification description text	DevImpOthAEModDescTxt	The reason for modification of original parameters or original electrode configuration of implanted device due to other Adverse Event (AE), specification	The reason for modification of original parameters or original electrode configuration of implanted device due to other Adverse Event (AE), specification	Other Adverse Event, specify			Alphanumeric		No references available	Adult;Pediatric	Supplemental	3.00	2013-07-30 14:29:49.047	Devices Log	Devices	Treatment/Intervention Data	255	Free-Form Entry
C14518	Device component type	DevCompTyp	The name of a part of the device that has a registration number or serial number	The name of a part of the device that has a registration number or serial number	Device Component Registration number or Serial number	INS;Lead;Extension	Implanted Nerve Stimulator (INS);Lead;Extension	Alphanumeric	Select the component(s) of the device as applicable. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data		Single Pre-Defined Value Selected
C18559	Device implanted serious adverse effect modification description text	DevImpSAEModDescrTxt	The reason for modification of original parameters or original electrode configuration of implanted device due to serious device adverse effect(s) specification	The reason for modification of original parameters or original electrode configuration of implanted device due to serious device adverse effect(s) specification	Serious Adverse Device Effect(s), specify			Alphanumeric		No references available	Adult;Pediatric	Supplemental	3.00	2013-07-30 14:29:49.047	Devices Log	Devices	Treatment/Intervention Data	255	Free-Form Entry
C14519	Device component registration or serial number	DevCompRegstrnSerialNum	The registration number or serial number of the device and component(s) to distinguish it from other devices (extension if applicable)	The registration number or serial number of a part of the device	Device Component Registration number or Serial number			Numeric Values	Enter all applicable device registration or serial number(s). Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data		Free-Form Entry
C18564	Device log line number	DevLogLineNum	The referenced line number of the entry on the device log	The referenced line number of the entry on the device lo	Line number			Numeric Values		No references available	Adult;Pediatric	Supplemental	3.00	2013-07-30 14:29:49.047	Devices Log	Devices	Treatment/Intervention Data		Free-Form Entry	0	20
C14520	Device stimulation target anatomic site	DevStimTargAntmicSite	The target of stimulation the device acts upon (where the device lead is located)	The part of the body the device is stimulating	Stimulation Target	Left Vagus Nerve;Hippocampus;Hippocampus: Left side;Hippocampus: Right side;AN;AN: Unilateral;AN: Bilateral;Other, specify	Left Vagus Nerve;Hippocampus;Hippocampus: Left side;Hippocampus: Right side;AN;AN: Unilateral;AN: Bilateral;Other, specify	Alphanumeric	Indicate stimulation target of device. Choose only one. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	1.00	2012-10-05 00:00:00.0	Devices Log	Devices	Treatment/Intervention Data		Single Pre-Defined Value Selected
C18955	Device implanted other text	DevImpOTH	The free-text field related to 'Device implanted type' specifying other text. The type of device used	The free-text field related to 'Device implanted type' specifying other text. The type of device used	Other, specify			Alphanumeric	Record the type of device. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data	4000	Free-Form Entry
C14521	Device lead type	DevLeadTyp	Type of insulated wires (leads) for the device implanted	Type of insulated wires (leads)	Type of Lead	VNS;Depth;Strip;Other, specify	VNS (Vagus Nerve Stimulation);Depth;Strip;Other, specify	Alphanumeric	Choose all that apply; if other specify. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data		Multiple Pre-Defined Values Selected
C18956	Device stimulation target anatomic other text	DevStimTargAntmicOTH	The free-text field related to 'Device stimulation target anatomic site' specifying other text. The target of stimulation the device acts upon (where the device lead is located)	The free-text field related to 'Device stimulation target anatomic site' specifying other text. The target of stimulation the device acts upon (where the device lead is located)	Other, specify			Alphanumeric	Indicate stimulation target of device. Choose only one. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	1.00	2012-10-05 00:00:00.0	Devices Log	Devices	Treatment/Intervention Data	4000	Free-Form Entry
C14522	Device lead contact count	DevLeadContctCt	The number of contacts of the insulated wires (leads)	The number of contacts of the insulated wires (leads)	Number of Contacts			Numeric Values	Indicate number of contacts for lead, if applicable. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data		Free-Form Entry
C18957	Device lead other text	DevLeadOTH	The free-text field related to 'Device lead type' specifying other text. Type of insulated wires (leads) for the device implanted	The free-text field related to 'Device lead type' specifying other text. Type of insulated wires (leads) for the device implanted	Type of Lead			Alphanumeric	Choose all that apply; if other specify. Core for all prospective intervention studies	No references available	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Devices Log	Devices	Treatment/Intervention Data	4000	Free-Form Entry