Transcutaneous vagus nerve stimulation with modified constraint-induced movement therapy for chronic stroke
Combined Effects of Transcutaneous Vagus Nerve Stimulation and Modified Constraint Induced Movement Therapy on Upper Extremity Function, Cognition and Quality of Life in Individual With Chronic Stroke
This study will try noninvasive vagus nerve stimulation together with modified constraint-induced movement therapy to improve arm movement, thinking, and quality of life in people with chronic left-sided stroke and moderate-to-severe arm weakness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Riphah International University Academic / other |
| Locations | 2 sites (Rawalpindi, Punjab Province and 1 other locations) |
| Trial ID | NCT07272239 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial enrolls people with chronic left-sided ischemic stroke (6 months–2 years) and moderate-to-severe upper-limb hemiparesis to receive transcutaneous auricular vagus nerve stimulation combined with modified constraint-induced movement therapy alongside routine physical therapy. Participants are randomized at two sites in Rawalpindi to receive active tVNS paired with intensive, task-specific arm training, with outcomes measured at baseline and after the intervention for motor function, cognition, and quality of life. Key eligibility includes NIHSS >6, MoCA ≥26, the ability to sit for therapy, and exclusion of global/receptive aphasia, severe spasticity (Modified Ashworth ≥3), significant other neurological or psychiatric disorders, severe apraxia or somatosensory loss, and low resting heart rate. The protocol uses noninvasive stimulation of the auricular branch of the vagus nerve timed with standardized mCIMT sessions to see if pairing neuromodulation with rehabilitation improves real-world arm use.
Who should consider this trial
Good fit: Ideal candidates are adults with left-sided ischemic stroke 6 months–2 years earlier who have moderate-to-severe upper-limb hemiparesis, NIHSS >6, MoCA ≥26, can sit for therapy, and do not have severe spasticity, global/receptive aphasia, or other major neurological or psychiatric disorders.
Not a fit: Patients with severe spasticity, global or receptive aphasia, major cognitive or sensory deficits, severe apraxia, very low resting heart rate, or other conditions that prevent safe participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, combining tVNS with mCIMT could increase arm strength and everyday hand use and improve cognition and quality of life for chronic stroke survivors.
How similar studies have performed: Implanted VNS paired with rehabilitation has shown benefit in prior randomized studies, and early small studies of noninvasive tVNS are promising but remain limited and exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Both male and female patients are included in the study. * Left sided ischemic stroke patients. * Patients with chronic, moderate-severe upper limb hemiparesis (\>6 months-2 years) * Stable participants having a stroke severity score \> 6 on National Institute of Health Stroke Scale (NIHSS). * Montreal Cognitive Assessment (MoCA) score ≥26. Exclusion Criteria: * Participants who show the symptoms of global or receptive aphasia. * Participants who have a history of significant neurological or psychiatric disorders, other than stroke, that could interfere with upper limb motor or sensory recovery. * Modified Ashworth scale score ≥ 3 of the affected upper extremity. * Patients who are not able to sit with or without support. * Patients with severe apraxia, somatosensory problems. * Resting heart rate (\< 50 beats/min). * Participants who are currently participating in another clinical trial or research study.
Where this trial is running
Rawalpindi, Punjab Province and 1 other locations
- Al- firdous physiotherapy clinic — Rawalpindi, Punjab Province, Pakistan (Recruiting)
- IIMCT- Railway General Hospital — Rawalpindi, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Aruba Saeed, Phd — Riphah International University
- Study coordinator: Zara Mansha, Ms-Nmpt
- Email: zaramansha09@gmail.com
- Phone: +923247502192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.