Phase 2
N=36
Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke
Stroke · Cerebrovascular Accident (CVA) · Hemiparesis
Bottom Line
View on ClinicalTrials.gov: NCT03592745 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep — 22.310; 7.010; 16.070; 10.055 percentage of MVC — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Transcutaneous Vagus Nerve Stimulation (tVNS) (Device); Sham Transcutaneous Vagus Nerve Stimulation (tVNS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep |
22.310; 7.010; 16.070; 10.055; 21.730; 13.545 | 0.002 sig |
| SECONDARY Median Change From Baseline in Upper Extremity Fugl Meyer Assessment Score |
2.000; 2.500; 2.330; 1.670 | 1.000 |
Summary
The purpose of this study is to evaluate if multiple therapy sessions of Transcutaneous Vagus Nerve Stimulation (tVNS) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy in a sham stimulation condition.
Eligibility Criteria
Inclusion Criteria
- Individuals between 18 and 85 years of age
- First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
- Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
- Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist).
Exclusion Criteria
- Botox treatment within 3 months of enrollment
- Fixed contraction deformity in the affected limb
- Complete and total flaccid paralysis of all shoulder and elbow motor performance
- Prior injury to the vagus nerve
- Severe dysphagia
- Introduction of any new rehabilitation interventions during study
- Individuals with scar tissue, broken skin, or irremovable metal piercings that may interfere with the stimulation or the stimulation device
- Highly conductive metal in any part of the body, including metal injury to the eye; this will be reviewed on a case by case basis for PI to make a determination
- Pregnant or plan on becoming pregnant or breastfeeding during the study period
- Significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI review)
- Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination
Data sourced from ClinicalTrials.gov (NCT03592745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.