A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-80
SponsorBeijing Pins Medical Co., Ltd
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- VNS
- Sham VNS
- Rehabilitation
Treatment groups
99 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov