Invasive Vagus Nerve Stimulation Paired With Rehabilitation After Stroke (NCT07736573) | Clinical Trial Compass
CompletedNot Applicable
Invasive Vagus Nerve Stimulation Paired With Rehabilitation After Stroke
China12 participantsStarted 2025-01-10
Plain-language summary
This study evaluated the feasibility, safety, and preliminary functional outcomes of invasive vagus nerve stimulation (iVNS) paired with upper-limb rehabilitation in participants with chronic stroke-related upper-limb motor dysfunction. Participants received cervical iVNS implantation followed by a 6-week supervised rehabilitation program and subsequent home-based rehabilitation. Changes in upper-limb motor function, spasticity, quality of life, and safety outcomes were assessed. Exploratory neuroimaging assessments using positron emission tomography/computed tomography and arterial spin labeling were performed in selected participants to evaluate changes in brain metabolism and perfusion.
Who can participate
Age range
18 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
. Adults aged 18 years or older.
. Documented history of stroke with persistent upper-limb motor dysfunction.
. Completion of invasive vagus nerve stimulation implantation.
. Completion of paired upper-limb rehabilitation after stimulation.
. Availability of clinical assessments during follow-up.
Exclusion criteria
. Other central nervous system disorders affecting motor function assessment.
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
1
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score
Timeframe: 6 weeks after initiation of rehabilitation