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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorLahore University of Biological and Applied Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous injury or surgical intervention of vagus nerve

Patients with cardiac arrest and arrythmias

Uncontrolled hypertension

Apraxia

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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 cervical branch along with task specific exercises

    Other intervention

    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

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Transcutaneous vagus nerve stimulation through auricular branch along with task specific exercisesExperimental treatment 1 intervention
Group B: Transcutaneous vagus nerve stimulation through cervical branch along with task specific exercisesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline, after 4 weeks, after 8 weeks
2

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.

Time frame
baseline, after 4 weeks, after 8 weeks
3

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.

Time frame
baseline, after 4 weeks, after 8 weeks

Secondary outcomes

1

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

The Stroke-Specific Quality of Life Scale (SS-QOL) is a comprehensive, self-report measure designed specifically to assess health-related quality of life in stroke survivors. The novel 17-item SS-QOL scale (SS-QOL-17) was constructed with the aim of providing a well-balanced measuring tool to depict QOL widely while ensuring the simplicity of administration. It consists of 17- items including mobility, energy, upper extremity function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking, and personality. Each item is rated on a 5-point Likert scale, with higher scores indicating better function. The total score ranges from 49 to 245, with domain scores calculated as the mean of item scores within each domain.

Time frame
baseline, after 4 weeks, after 8 weeks

Other outcomes

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