Comperative Effects of Transcutaneous Auricular and Cervical Vagus Nerve Stimulation in Subacute … (NCT07253870) | Clinical Trial Compass
RecruitingNot Applicable
Comperative Effects of Transcutaneous Auricular and Cervical Vagus Nerve Stimulation in Subacute Stroke Patients
Pakistan54 participantsStarted 2025-11-20
Plain-language 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.
Who can participate
Age range
45 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two types of vagus nerve stimulation — one through the ear and one through the neck — so could you explain what each of those procedures actually involves and whether either one would be safe given my specific stroke history and recovery so far?
2Since this trial is enrolling subacute stroke patients, how do you define 'subacute' and does my current stage of recovery actually fall within the window they're looking for?
3The trial is measuring upper limb movement using the Fugl-Meyer and Wolf Motor Function tests — given where my arm function is right now, do you think I'm a realistic candidate, and could participating help or interfere with my current rehabilitation plan?
4The trial also measures cognitive function using the MoCA, so does that mean vagus nerve stimulation might affect both my movement and my thinking after stroke, and is there anything in my situation that would make one of those outcomes more important to focus on?
5Since this is a Phase NA comparative study that's still enrolling, what do we know so far about the safety of non-invasive vagus nerve stimulation in stroke recovery, and are there standard therapies I should try first before considering something experimental like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fugl-meyer assessment of upper limb (FMA-UE)
Timeframe: baseline, after 4 weeks, after 8 weeks
2
Montreal cognitive assessment (MoCA)
Timeframe: baseline, after 4 weeks, after 8 weeks
3
Wolf Motor Function Test (WMFT)
Timeframe: baseline, after 4 weeks, after 8 weeks
Trial details
NCT IDNCT07253870
SponsorLahore University of Biological and Applied Sciences