Rehabilitation Paired with VNS for Motor Function Recovery

Launched by FIRST AFFILIATED HOSPITAL OF FUJIAN MEDICAL UNIVERSITY · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well vagus nerve stimulation (VNS) combined with rehabilitation can help improve the use of the arm after a spontaneous brain bleed, known as intracerebral hemorrhage (ICH). The trial aims to find out if this treatment is safe and effective compared to a placebo (a treatment that doesn't have the active ingredient). Participants will have a small device surgically implanted in their body to provide VNS and will then take part in therapy sessions for six weeks, followed by six weeks of home exercises. Depending on which group they are in, they may either continue with more therapy or focus on their home exercises.

To be eligible for this study, participants should be between 22 and 80 years old, have had a brain bleed at least six months ago but less than five years ago, and have some weakness in one arm. They should also be able to understand instructions and follow them. However, individuals with certain conditions, like a history of other types of strokes or specific nerve problems, won't be able to join the trial. If someone is selected, they can expect to receive support throughout the process but will need to commit to attending appointments and following the treatment plan.

Gender

ALL

Eligibility criteria

• 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 any other stimulation device, such as a pacemaker or other neurostimulator.
• • Pregnancy or plans to become pregnant or to breastfeed during the study period.
• • Participated in any other clinical trials within the preceding 3 months.
• • Not considered to be applicable by the investigator.