Your session is about to expire
← Back to Search
Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke (tVNS Trial)
Phase 2
Waitlist Available
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)
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.
Eligible Conditions
- Stroke
- Hemiparesis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep
Secondary study objectives
Median Change From Baseline in Upper Extremity Fugl Meyer Assessment Score
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: active tVNS + robotic arm therapyExperimental Treatment1 Intervention
Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Group II: sham tVNS + robotic arm therapyPlacebo Group1 Intervention
Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Vagus Nerve Stimulation (tVNS)
2018
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
475 Previous Clinical Trials
469,248 Total Patients Enrolled
11 Trials studying Stroke
352 Patients Enrolled for Stroke