Trial Outcomes & Findings for taVNS for Upper Limb Rehabilitation (NCT NCT04129242)

Last Updated: 2024-02-28

Results Overview

The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Possible aggregate scores range from 0/66 to 66/66 points. Higher scores indicate greater levels of arm movement ability.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Mean change in FMA-UE score after 4 weeks of rehab, compared to baseline

Results posted on

2024-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	"Paired" taVNS + Task Specific Training Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.	"Unpaired" taVNS + Task Specific Training Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.
Overall Study STARTED	10	10
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	"Paired" taVNS + Task Specific Training Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.	"Unpaired" taVNS + Task Specific Training Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.
Overall Study Physician Decision	1	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

taVNS for Upper Limb Rehabilitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	"Paired" taVNS + Task Specific Training n=9 Participants Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.	"Unpaired" taVNS + Task Specific Training n=7 Participants Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	57.33 years STANDARD_DEVIATION 8.28 • n=5 Participants	58.71 years STANDARD_DEVIATION 6.45 • n=7 Participants	57.93 years STANDARD_DEVIATION 7.34 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Mean change in FMA-UE score after 4 weeks of rehab, compared to baseline

Population: Adults with unilateral motor deficits post-stroke

Outcome measures

Outcome measures
Measure	"Paired" taVNS + Task Specific Training n=9 Participants Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.	"Unpaired" taVNS + Task Specific Training n=7 Participants Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training: A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.
Change in Fugl-Meyer Assessment of the Upper Extremity	5 score on a scale Standard Error 1.02	3.14 score on a scale Standard Error 0.63

Adverse Events

"Paired" taVNS + Task Specific Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

"Unpaired" taVNS + Task Specific Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bashar Badran

The Medical University of SC

Phone: 843-792-6076

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place