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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
VNS
DeviceAn neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve.
Sham VNS
DeviceAn neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA.
Rehabilitation
Other interventionRehabilitation movements to improve upper limb function after stroke.
Treatment groups
99 Participants
are divided into 2 treatment groupsGroup A: VNS groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change
The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment). The FMA-UE will be analyzed for difference in average change at Clinic rehabilitation follow-up timepoint compared to Baseline follow-up timepoint (Difference in average change in FMA-UE from V3 to V4).
Time frame
V4, 6 weeks after Baseline follow-up timepointSecondary outcomes
1
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Response
The Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Response is the percent of patients with a 6 point or greater improvement on the FMA-UE.
Time frame
V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint2
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change
The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Time frame
V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint3
Wolf Motor Function Test (WMFT) Average Change
The Wolf Motor Function Test (WMFT) is an assessment scale of upper extremity functional level after stroke. The functional assessment range is an average of 15 sub-items with a range from 0 to 5, with 0 (meaning did not attempt) to 5 (meaning normal).
Time frame
V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint4
Wolf Motor Function Test (WMFT) Response
Wolf Motor Function Test (WMFT) Response is the percent of patients with a 0.4 point or greater improvement on the WMFT.
Time frame
V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepointSponsors and contacts
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Source ClinicalTrials.gov