Comperative Effects of Transcutaneous Auricular and Cervical Vagus Nerve Stimulation in Subacute Stroke Patients

NCT07253870 | Recruiting DMC

• 1 other identifier: UBAS/ERB/FoRS/25/O32 Wafa
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether transcutaneous vagus nerve stimulation (tVNS) via auricular or cervical branches enhances recovery when combined with task-specific training in subacute stroke patients. We anticipate finding that both stimulation methods may improve upper limb motor function compared to conventional therapy. The research is expected to reveal specific cognitive domains (attention, memory, executive function) that benefit most from each stimulation approach, while also demonstrating meaningful improvements in patients' quality of life measures. These findings may make a significant practical contribution by providing clinicians with evidence-based guidance on suitable tVNS approach for improving functional independence and quality of life for stroke survivors.

Conditions

Stroke; Stroke, Acute

Keywords

Task Specific Training; Upper Limb Function; Cognition

Outcome Measures

Primary Outcomes (3)

• Fugl-meyer assessment of upper limb (FMA-UE)

  The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a commonly utilized tool for measuring motor impairment in stroke rehabilitation. The FMA-UE has demonstrated excellent test-retest and inter- and intra-rater reliability, and evidence for its content validity in acute and subacute populations has been widely reported. The UE section of the FMA consists of 33 items and is scored on a 3-point ordinal scale with 0 meaning cannot perform, 1 meaning can partially perform, and 2 meaning can perform fully. Scores are summed with a maximum potential score of 66 points.

  baseline, after 4 weeks, after 8 weeks

• Montreal cognitive assessment (MoCA)

  The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal. These findings suggest that MoCA is a reliable and valid tool for detecting major neurocognitive disorders in older populations.

  baseline, after 4 weeks, after 8 weeks

• Wolf Motor Function Test (WMFT)

  The Wolf Motor Function Test (WMFT) is a standardized assessment tool designed to evaluate upper extremity motor function in individuals who have suffered a stroke or other neurological impairments. It measures the ability to perform tasks that require reaching, grasping, and manipulating objects, focusing on both speed and quality of movement. It is a 21 items scale, ranging from simple movements to more complex actions, allowing for a comprehensive evaluation of motor skills. The items are rated on a 6-point scale, it took approximately 30 minutes.

  baseline, after 4 weeks, after 8 weeks

Secondary Outcomes (1)

• Stroke-Specific Quality of Life Scale (SS-QOL)

  baseline, after 4 weeks, after 8 weeks

Study Arms (2)

Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises

EXPERIMENTAL

Group A will receive application of TENS to stimulate the vagus nerve at the ear level, apply the clip electrodes at the targus/cymba concha and the other electrode anywhere in the skin over neck along with task specific exercises

Other: Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises

Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises

ACTIVE COMPARATOR

Group B will receive application of TENS to stimulate the vagus nerve at the neck level, apply the pad electrodes at the anterior mid to neck and the other electrode over back of neck along task specific exercises

Other: Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises

Interventions

Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises OTHER

Group A will receive application of TENS to stimulate the vagus nerve at the ear level, apply the clip electrodes at the targus/cymba concha and the other electrode anywhere in the skin over neck Mode on TENS will be normal, with the width pulse of 250µs. FITT will be as follow Frequency of 25 Hz, Intensity 1mA, Time 30 minutes and the treatment will be of 5 days a week for 8 consecutive weeks * For grip and release: Use a soft ball, putty, or other textured objects. The patient squeezes the object to strengthen their grip and then releases it. * Reaching task: Place objects at varying distances in front of the patient. Encourage them to reach out with the affected arm to grasp the items and then bring them back. * Bilateral arm movement: Encourage simultaneous reaching or moving with both arms (e.g., pushing against a wall or lifting a lightweight object) to promote symmetry and coordination. Improve coordination and function of both arms. * Tabletop activities: Engaging in activities lik

Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises

Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises OTHER

Group B will receive application of TENS to stimulate the vagus nerve at the neck level, apply the pad electrodes at the anterior mid to neck and the other electrode over back of neck Mode on TENS will be normal, with the width pulse of 250µs. FITT will be as follow Frequency of 25 Hz, Intensity 1mA, Time 30 minutes and the treatment will be of 5 days a week for 8 consecutive weeks * For grip and release: Use a soft ball, putty, or other textured objects. The patient squeezes the object to strengthen their grip and then releases it. * Reaching task: Place objects at varying distances in front of the patient. Encourage them to reach out with the affected arm to grasp the items and then bring them back. * Bilateral arm movement: Encourage simultaneous reaching or moving with both arms (e.g., pushing against a wall or lifting a lightweight object) to promote symmetry and coordination. Improve coordination and function of both arms. * Tabletop activities: Engaging in activities like sortin

Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercises

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (1)

Shadman Medical Center, Stroke Rehabilitation

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

Related Publications (4)

• Hays SA, Rennaker RL, Kilgard MP. Targeting plasticity with vagus nerve stimulation to treat neurological disease. Prog Brain Res. 2013;207:275-99. doi: 10.1016/B978-0-444-63327-9.00010-2.

  PMID: 24309259 BACKGROUND

• Hilz MJ. Transcutaneous vagus nerve stimulation - A brief introduction and overview. Auton Neurosci. 2022 Dec;243:103038. doi: 10.1016/j.autneu.2022.103038. Epub 2022 Sep 27.

  PMID: 36201901 BACKGROUND

• Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr;236(4):588-611. doi: 10.1111/joa.13122. Epub 2019 Nov 19.

  PMID: 31742681 BACKGROUND

• Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.

  PMID: 32837228 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aruba Saeed

  Lahore University of Biological and Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wafa Mansha, DPT

CONTACT

+92266303005; wafamalik583@gmail.com

Aruba Saeed, PhD

CONTACT

+923344399403; arubasaeedpt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: outcome assessor will be blind about participants allocation. this will ensure that their evaluations are objective and not influenced by knowledge of which treatment group participants belong to. Participants in both groups will be masked to the treatment of the other group by scheduling their sessions at different times.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional study model for this study is a parallel-group randomized clinical trial (RCT). This model involves two distinct groups: Treatment Group A Participants will receive transcutaneous vagus nerve stimulation through auricular branch along with task specific exercises Treatment Group B Participants will receive transcutaneous vagus nerve stimulation through cevical branch along with task specific exercises Each participant is assigned randomly to one of these groups, ensuring that comparisons between the groups is unbiased. This parallel structure means each group undergoes its specific intervention throughout the study period without crossover to the other group's intervention. This approach helps assess the suitable tVNS approach for improving functional independence and quality of life for stroke survivors

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)