Not Yet RecruitingNot Applicable

Rehabilitation Paired with VNS for Motor Function Recovery

10 participantsStarted 2025-04-01

Plain-language summary

The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) combined with rehabilitation in improving upper extremity motor function after spontaneous intracerebral hemorrhage (ICH). Researchers will evaluate the efficacy and safety of VNS by comparing the improvements of arm motor function post-ICH in the active VNS combined rehabilitation group with that in the sham VNS combined rehabilitation group (actual intensity 0 mA). Participants in this study will undergo a surgical procedure to implant the VNS system and will subsequently recieve a 6 weeks in-clinic therapy, followed by an additional 6 weeks home exercise. During the final 6 weeks, participants will either recieve in-clinic therapy or maintain their home exercise, depending on their assigned group.

Who can participate

Age range

22 Years – 79 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: * Age ≥22 years and \<80 years, all gender is acceptable. * History of unilateral supratentorial intracerebral hemorrhage ≥ 6 months but \< 5 years. * Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50. * Right- or left-sided weakness of upper extremity. * Ability to communicate, understand, and give appropriate consent. Subjects can follow trial commands. * Subjects have good compliance and can complete the visits after surgery. Exclusion Criteria: * History of ischemic stroke. * Cerebral hemorrhage resulting from tumors, trauma, aneurysms, or hemorrhagic transformation of ischemic stroke. * Presence of ongoing dysphagia or aspiration difficulties. * Prior injury to vagus nerve, either bilateral or unilateral. * Subject receiving medication that may significantly interfere with actions of VNS on neurotransmitter systems at study entry, clinic rehabilitation follow-up timepoint, or home rehabilitation follow-up timepoint, such as centrally acting cholinoceptor blockers, centrally acting adrenoceptor blockers, norepinephrine re-uptake inhibitors, etc. * Botox injections within 4 weeks prior to enrollment through the unmasking follow-up timepoint (Visit 6). * Severe spasticity of the upper extremity (Modified Ashworth ≥ 3). * Significant sensory loss of the upper extremity (Upper Extremity sensory section of the Fugl-Meyer Assessment score \< 6). * Current requirement, or likely future requirement, of diathermy. * Current use of …

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change

Timeframe: V4, 6 weeks after baseline follow-up timepoint

Trial details

NCT IDNCT06892574

SponsorFirst Affiliated Hospital of Fujian Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Fuxin Lin

13600893154 lfxstudy@126.com

View on ClinicalTrials.gov More Spontaneous Intracerebral Hemorrhage trials