Transcutaneous vagus nerve stimulation with modified constraint-induced movement therapy for chronic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.