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

Not Applicable

Recruiting

• Conditions: Ischemic Stroke; Upper Extremity Paresis

• Registration Number: NCT06722677
• Lead Sponsor: Beijing Pins Medical Co., Ltd

Brief 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.

Detailed Description

There are 6 follow-up timepoints in this trial:

1. Screening follow-up timepoint (V1): All participants will sign the informed consent form and receive pre-implant evaluation, including physical examination, brain magnetic resonance imaging, FMA-UE, WMFT, modified Ashworth sacle, BDI, ect.

2. Surgery follow-up timepoint (V2):All participants will be implanted with the VNS system, including the G115R IPG and L312 lead.

3. Baseline follow-up timepoint (V3): There is a baseline evaluation 7 to 14 days after the surgery, then participants will be randomly assigned to VNS group or Control group. The randomization will be stratified by baseline FMA-UE (20 to 35, 36 to 50), age (\<50, ≥50) and research center (south centers, north centers).

4. Clinic rehabilitation follow-up timepoint (V4): Participants will receive standard clinic rehabilitation 3 days per week and lasting 6 weeks. Active VNS (VNS group) or sham VNS (Control group) will be paired with rehabilitation. Participants will be evaluated at the last day of this follow-up timepoint.

5. Home exercise follow-up timepoint (V5): Participants will take standard home exercise everyday in 6 weeks. Active VNS (VNS group) or sham VNS (Control group) will be paired with rehabilitation. At the last day, after evaluating, group assignment is unblinded.

6. Unmasking follow-up timepoint (V6): In this 6 weeks, all participants will receive active VNS. Participants in VNS group will still take standard home exercise, and participants in Control group will receive standard clinic rehabilitation again. Participants will be also evaluated at the last day of this follow-up timepoint.

Study Timeline

• Study First Submitted: 2024-11-10
• Study Start: 2024-11-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-08
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 99

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change	V4, 6 weeks after Baseline follow-up timepoint	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).

Secondary Outcome Measures

Name	Time	Method
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change	V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint	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).
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Response	V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint	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.
Wolf Motor Function Test (WMFT) Average Change	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 timepoint	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).
Wolf Motor Function Test (WMFT) Response	V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint	Wolf Motor Function Test (WMFT) Response is the percent of patients with a 0.4 point or greater improvement on the WMFT.
Beck Depression Inventory (BDI) Average Change	V6, 6 weeks after Home exercise follow-up timepoint	The Beck Depression Inventory (BDI) is a self-report questionnaire used to identify overt behavioral characteristics of depression. Items are scored on a 4-point scale that ranges from 0 to 3. Ratings are summed to provide a total score ranging from 0 to 63.
Montreal Cognitive Assessment (MoCA) Average Change	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 timepoint	MoCA is designed to assess cognitive function in patients. It assesses a number of different cognitive domains, including visuospatial and executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total score is 30, with higher scores indicating better cognitive function.
Motor Activity Log (MAL) Average Change	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 timepoint	The Motor Activity Log (MAL) consists of 30 activities of daily living such as using a towel, brushing teeth, and picking up a glass. The individual is asked to rate how often and how well each activity was performed with the more impaired arm. The response scale ranges from zero (never used) to 5 (same as pre-stroke)
Stroke impact scale (SIS) Average Change	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 timepoint	The Stroke Impact Scale (SIS) is a self-reported measure of stroke outcomes. Each item is selfrated on a 5-point Likert scale in terms of the difficulty the person has experienced in completing them after the score.
EQ-5D-3L Average Change	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 timepoint	The EQ-5D-3L is a general measure of health outcomes in any population. It is a self-report questionnaire which provides a simple descriptive profile and a single index value for health status.
Incidence of Adverse Events	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 timepoint	The incidence of adverse events occurred during the clinical trial, whether or not related to the device.

Trial Locations

Locations (2)

The First Affiliated Hospital of USTC; 🇨🇳 Hefei, Anhui, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China