A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)
A Multi-Center, Triple-Blind, Randomized, Sham-Controlled Trial Assessing the Efficacy and Safety of Rehabilitation Paired with Vagus Nerve Stimulation for Upper Extremity Motor Function in Patients with Ischemic Stroke (Repair Study)
Beijing Pins Medical Co., Ltd
99 participants
Nov 19, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) paired with rehabilitation for enhancing upper extremity motor function after ischemic stroke. Researchers will compare the outcomes of active VNS paired with rehabilitation against sham VNS (the actual intensity is 0 mA) also paired with rehabilitation, in order to assess improvements in arm motor function post-stroke. 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.
Eligibility
Inclusion Criteria6
- Age ≥22 years and \<80 years, all gender is acceptable.
- History of unilateral supratentorial ischemic stroke ≥ 9 months but \< 10 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 Criteria13
- History of hemorrhagic 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).
- Severe depression (Beck Depression Scale \> 29).
- 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.
Interventions
An neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve.
An neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA.
Rehabilitation movements to improve upper limb function after stroke.
Locations(16)
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NCT06722677