Actively Recruiting
A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)
Led by Beijing Pins Medical Co., Ltd · Updated on 2024-12-10
99
Participants Needed
16
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older and younger than 80 years, any gender
- History of unilateral supratentorial ischemic stroke at least 9 months but less than 10 years ago
- Upper Extremity Fugl-Meyer Assessment motor score between 20 and 50
- Weakness on the right or left side of the upper extremity
- Ability to communicate, understand, and give informed consent
- Ability to comply with study visits after surgery
You will not qualify if you...
- History of hemorrhagic stroke
- Current problems with swallowing or aspiration
- Previous injury to the vagus nerve on either side
- Use of medications that interfere with VNS effects on neurotransmitters at any study timepoint
- Botox injections within 4 weeks before enrollment through the end of the study
- Severe spasticity of the upper extremity (Modified Ashworth score 3 or higher)
- Significant loss of sensation in the upper extremity (Fugl-Meyer sensory score less than 6)
- Severe depression (Beck Depression Inventory score over 29)
- Current or expected future need for diathermy treatment
- Use of other stimulation devices like pacemakers or neurostimulators
- Pregnancy, planning pregnancy, or breastfeeding during the study
- Participation in other clinical trials within the last 3 months
- Considered ineligible by the investigator
AI-Screening
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Trial Site Locations
Total: 16 locations
1
The First Affiliated Hospital of USTC
Hefei, Anhui, China, 230022
Not Yet Recruiting
2
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
3
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China, 100039
Not Yet Recruiting
4
The Xin Qiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China, 400037
Not Yet Recruiting
5
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350004
Actively Recruiting
6
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510260
Actively Recruiting
7
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530012
Actively Recruiting
8
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China, 430030
Actively Recruiting
9
Brain Hospital of Hunan Province The Second People's Hospital of Hunan Province
Changsha, Hunan, China, 410000
Not Yet Recruiting
10
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing university Medical School
Nanjing, Jiangsu, China, 210008
Not Yet Recruiting
11
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
12
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
13
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
14
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
15
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 618099
Not Yet Recruiting
16
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
Research Team
J
Jianguang Sun
CONTACT
B
Baichuan He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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