Trial Outcomes & Findings for High Definition Neuromuscular Stimulation in Tetraplegia (NCT NCT04075812)

Last Updated: 2021-08-09

Results Overview

consistent and repetitive voluntary movement in the targeted muscle groups as assessed by investigator(s)- no formal scale is used. The participant(s) started out with paralysis due to spinal cord injury, so any active voluntary movement consists of a qualitative change in movement.

Recruitment status

COMPLETED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

through study completion, up to 60 months

Results posted on

2021-08-09

Participant Flow

Recruited from Tertiary Care Center

Participant milestones

Participant milestones
Measure	Neuromuscular Stimulator Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements. Neuromuscular Stimulator
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Definition Neuromuscular Stimulation in Tetraplegia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neuromuscular Stimulator n=2 Participants Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements. Neuromuscular Stimulator
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	2 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	2 participants n=5 Participants

PRIMARY outcome

Timeframe: through study completion, up to 60 months

Population: All enrolled patients were able to generate consistent and repetitive movement in targeted muscle groups

Outcome measures

Outcome measures
Measure	Neuromuscular Stimulator n=2 Participants Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements. Neuromuscular Stimulator
Change in Voluntary Movement Evoked movement - able	2 Participants
Change in Voluntary Movement Evoked movement - unable	0 Participants

SECONDARY outcome

Timeframe: through study completion, up to 60 months

Population: Consistent functional movement for object manipulation

consistent movement in the targeted muscle groups that is functional (manipulate or pick up an object); as assessed by investigator(s) for task completion- no formal scale used Objects were taken from the Action Research Arm Task, Grasp and Release Task, GRASSP as well as using household objects (phone, cup, spoon)

Outcome measures

Outcome measures
Measure	Neuromuscular Stimulator n=2 Participants Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements. Neuromuscular Stimulator
Change in Functional Movement Evoked object manipulation - able	2 Participants
Change in Functional Movement Evoked object manipulation - unable	0 Participants

Adverse Events

Neuromuscular Stimulator

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neuromuscular Stimulator n=2 participants at risk Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements. Neuromuscular Stimulator
Skin and subcutaneous tissue disorders Device-related SAE (anticipated)	50.0% 1/2 • Number of events 1 • from baseline through study completion, up to 60 months Per clinicaltrials.gov definitions

Other adverse events

Other adverse events
Measure	Neuromuscular Stimulator n=2 participants at risk Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements. Neuromuscular Stimulator
Renal and urinary disorders Non-device related AE associated with spinal cord injury (anticipated)	100.0% 2/2 • Number of events 2 • from baseline through study completion, up to 60 months Per clinicaltrials.gov definitions
Skin and subcutaneous tissue disorders Non-device related AE associated with spinal cord injury (anticipated)	50.0% 1/2 • Number of events 2 • from baseline through study completion, up to 60 months Per clinicaltrials.gov definitions

Additional Information

Marcia Bockbrader MD PhD

The Ohio State University

Phone: 6142933127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place