Comparing ear versus neck vagus nerve stimulation plus task training for subacute stroke recovery

Comparative Effects of Transcutaneous Auricular and Cervical Vagus Nerve Stimulation on Upper Limb Function, Cognition and Quality of Life in Subacute Stroke Patients

This trial will test whether gentle electrical stimulation of the vagus nerve at the ear or neck, combined with task-specific arm training, helps people 3–6 months after an ischemic stroke recover arm function and thinking skills.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 45 Years to 70 Years
• Sex: All
• Sponsor: Lahore University of Biological and Applied Sciences (other)
• Locations: 1 site (Lahore, Punjab Province)
• Trial ID: NCT07253870 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls people 3–6 months after a first ischemic stroke with moderate upper-limb impairment (FMA-UE 20–50) to receive transcutaneous vagus nerve stimulation (tVNS) delivered either at the auricular or cervical branch alongside task-specific upper-limb exercises. Participants will undergo a program of paired stimulation and therapy with outcome measures focused on upper-limb motor function, cognitive domains (attention, memory, executive function), and quality of life. The protocol compares the two tVNS delivery sites to determine which approach provides greater functional gains when combined with rehabilitation. Safety and tolerability will also be recorded, and standard exclusion criteria (cardiac arrhythmias, implanted electronic devices, prior vagus nerve surgery, uncontrolled hypertension, apraxia, other neurologic/musculoskeletal disease) are applied.

Who should consider this trial

Good fit: Ideal candidates are people with a first-ever ischemic stroke 3–6 months after onset who have moderate upper-limb impairment (FMA-UE 20–50) and no implanted electronic devices or uncontrolled cardiac conditions.

Not a fit: Patients with prior vagus nerve injury or surgery, implanted electronic devices, uncontrolled hypertension, cardiac arrhythmias, apraxia, other major neurologic or musculoskeletal diseases, or non-ischemic (hemorrhagic) strokes are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could offer a noninvasive, low-cost way to speed recovery of arm movement, certain cognitive skills, and daily function for subacute ischemic stroke survivors.

How similar studies have performed: Previous small trials and pilot studies pairing vagus nerve stimulation with rehabilitation have shown promising improvements in motor recovery, but direct comparisons of transcutaneous auricular versus cervical approaches are novel.

Eligibility criteria

Inclusion Criteria:

* First ever ischemic stroke
* Subacute phase of stroke 3-6 months post onset
* Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores ranged from 20 - 50

Exclusion Criteria:

* Previous injury or surgical intervention of vagus nerve
* Patients with cardiac arrest and arrythmias
* Uncontrolled hypertension
* Apraxia
* Other neurologic or musculoskeletal diseases
* Presence of implanted electronic devices

Where this trial is running

Lahore, Punjab Province

• Shadman Medical Center, Stroke Rehabilitation — Lahore, Punjab Province, Pakistan (RECRUITING)

Study contacts

• Principal investigator: Aruba Saeed — Lahore University of Biological and Applied Sciences
• Study coordinator: Wafa Mansha, DPT

Conditions: Stroke, Stroke, Acute, Task Specific Training, Upper Limb Function, Cognition