Trial Outcomes & Findings for Reanimation in Tetraplegia (NCT NCT01997125)

Last Updated: 2021-08-31

Results Overview

The primary outcome measure of this study is the achievement of voluntary hand movement using the neural bridge system

Recruitment status

COMPLETED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

9 months

Results posted on

2021-08-31

Recruited 2013-2015 from a tertiary care center rehabilitation clinic

Participant milestones
Measure	Neural Bridge System - Open Label Neural bridge system implant and external stimulator Neural Bridge System: Implanted device
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Reanimation in Tetraplegia

Baseline characteristics by cohort
Measure	Neural Bridge System - Open Label n=1 Participants Neural bridge system implant and external stimulator Neural Bridge System: Implanted device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants
Number of participants with voluntary movement Evoked movement - able	0 Participants n=5 Participants
Number of participants with voluntary movement Evoked movement - unable	1 Participants n=5 Participants

Timeframe: 9 months

The primary outcome measure of this study is the achievement of voluntary hand movement using the neural bridge system

Outcome measures
Measure	Neural Bridge System - Open Label n=1 Participants Neural bridge system implant and external stimulator Neural Bridge System: Implanted device
Number of Participants With Voluntary Movement Voluntary Movement - able	1 Participants
Number of Participants With Voluntary Movement Voluntary Movement - unable	0 Participants

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events
Measure	Open Label n=1 participants at risk Neural bridge system implant and external stimulator Neural Bridge System: Implanted device
General disorders Unanticipated, device-related SAE	100.0% 1/1 • Number of events 1 • 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term, please consider making this explicit in the Adverse Event Reporting Description

Other adverse events
Measure	Open Label n=1 participants at risk Neural bridge system implant and external stimulator Neural Bridge System: Implanted device
Skin and subcutaneous tissue disorders Non-device related AE associated with spinal cord injury (anticipated)	100.0% 1/1 • Number of events 1 • 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term, please consider making this explicit in the Adverse Event Reporting Description
Renal and urinary disorders Non-device related AE associated with spinal cord injury (anticipated)	100.0% 1/1 • Number of events 1 • 5 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term, please consider making this explicit in the Adverse Event Reporting Description

The Ohio State University

Phone: 6142937604