Actively Recruiting

Phase Not Applicable
Age: 45Years - 70Years
All Genders
ID07253870

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

Led by Lahore University of Biological and Applied Sciences · Updated on 2025-12-03

54

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

This research aims to evaluate whether transcutaneous vagus nerve stimulation (tVNS) applied via the auricular or cervical branches can improve recovery when combined with task-specific training in patients who have had a subacute stroke. The study focuses on upper limb motor function and cognitive areas such as attention, memory, and executive function. It also seeks to understand how each stimulation method may enhance quality of life, providing valuable guidance for clinical rehabilitation of stroke survivors. Participants are divided into two groups: one group receives tVNS through the auricular branch using TENS applied at the ear level with clip electrodes, and the other group receives tVNS through the cervical branch with pad electrodes applied to the neck. Both groups perform task-specific exercises including grip and release tasks, reaching activities, bilateral arm movements, and tabletop activities. Treatments last 30 minutes per session, five days a week, for eight consecutive weeks. Throughout the study, participants undergo assessments at baseline, after 4 weeks, and after 8 weeks. These include tests for upper limb function (Fugl-Meyer Assessment, Wolf Motor Function Test), cognitive abilities (Montreal Cognitive Assessment), and quality of life (Stroke-Specific Quality of Life Scale). The study involves randomized assignment and double masking to compare the effects of the two stimulation methods on recovery. Safety and progress are monitored throughout the treatment and follow-up periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 45Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • First ever ischemic stroke
  • Stroke in subacute phase, 3 to 6 months after onset
  • Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score between 20 and 50
  • Age between 45 and 70 years
Not Eligible

You will not qualify if you...

  • Previous injury or surgical intervention of the vagus nerve
  • History of cardiac arrest or arrhythmias
  • Uncontrolled high blood pressure
  • Apraxia
  • Other neurological or musculoskeletal diseases
  • Presence of implanted electronic devices

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive transcutaneous vagus nerve stimulation through either the auricular or cervical branch combined with task specific exercises to improve upper limb function and cognition after stroke.

5 visits per week for 8 consecutive weeks

Trial Site Locations

Total: 1 location

1

Shadman Medical Center, Stroke Rehabilitation

Lahore, Punjab Province, Pakistan, 54660

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Research Team

W

Wafa Mansha, DPT

A

Aruba Saeed, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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