A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)

Launched by BEIJING PINS MEDICAL CO., LTD · Dec 4, 2024

Keywords

ClinConnect Summary

The Repair Study is investigating how effective and safe a treatment called vagus nerve stimulation (VNS) is when combined with rehabilitation for improving arm movement in patients who have had an ischemic stroke. This type of stroke happens when blood flow to the brain is blocked, leading to weakness in one side of the body. In this trial, researchers will compare the effects of real VNS, which stimulates the vagus nerve, with a sham version that doesn't provide any real stimulation but still allows participants to receive rehabilitation therapy.

To be eligible for this study, participants should be between 22 and 80 years old, have experienced a stroke at least 9 months but less than 10 years ago, and have some weakness in one arm but still be able to follow instructions and give consent. Those who join the study will have a small device surgically implanted to deliver VNS, followed by 6 weeks of therapy in a clinic and another 6 weeks of home exercises. Participants will either continue their therapy in the clinic or at home during the final 6 weeks, depending on the group they are assigned to. This trial is currently recruiting participants, and it’s important for anyone considering joining to discuss any medical history or medications with their doctor to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥22 years and \<80 years, all gender is acceptable.
• • 2. History of unilateral supratentorial ischemic stroke ≥ 9 months but \< 10 years.
• • 3. Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50.
• • 4. Right- or left-sided weakness of upper extremity.
• • 5. Ability to communicate, understand, and give appropriate consent. Subjects can follow trial commands.
• • 6. Subjects have good compliance and can complete the visits after surgery.
• Exclusion Criteria:
• • 1. History of hemorrhagic stroke.
• • 2. Presence of ongoing dysphagia or aspiration difficulties.
• • 3. Prior injury to vagus nerve, either bilateral or unilateral.
• • 4. 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.
• • 5. Botox injections within 4 weeks prior to enrollment through the unmasking follow-up timepoint (Visit 6).
• • 6. Severe spasticity of the upper extremity (Modified Ashworth ≥ 3).
• • 7. Significant sensory loss of the upper extremity (Upper Extremity sensory section of the Fugl-Meyer Assessment score \< 6).
• • 8. Severe depression (Beck Depression Scale \> 29).
• • 9. Current requirement, or likely future requirement, of diathermy.
• • 10. Current use of any other stimulation device, such as a pacemaker or other neurostimulator.
• • 11. Pregnancy or plans to become pregnant or to breastfeed during the study period.
• • 12. Participated in any other clinical trials within the preceding 3 months.
• • 13. Not considered to be applicable by the investigator.