Actively Recruiting
Led by Beijing Pins Medical Co., Ltd · Updated on 2024-12-10
99
Participants Needed
16
Research Sites
13 weeks
Total Duration
Researchers are investigating the use of vagus nerve stimulation (VNS) combined with rehabilitation to improve arm movement after an ischemic stroke. This clinical trial compares active VNS paired with rehabilitation against a sham VNS with no electrical stimulation, also combined with rehabilitation, to assess their effects on upper extremity motor function in stroke patients. The study is conducted with a triple-blind, randomized, sham-controlled design and aims to evaluate both safety and efficacy.
CONDITIONS
A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and pre-implant evaluations including physical examination and brain MRI
Duration - 1 day
Participants undergo implantation of the Vagus Nerve Stimulation (VNS) system.
1 visit (in-person) for VNS system implantation
Duration - 7 to 14 days
Participants receive baseline assessments 7 to 14 days after surgery before randomization.
1 visit (in-person) for baseline evaluation and randomization
Duration - 6 weeks
Participants receive standard clinic rehabilitation paired with active or sham VNS three days per week for 6 weeks.
Approximately 18 clinic visits (3 days per week for 6 weeks) plus evaluations at the last day
Duration - 6 weeks
Participants continue standard home exercise daily paired with active or sham VNS for 6 weeks.
Daily home exercises with evaluation on the last day
Duration - 6 weeks
All participants receive active VNS; those previously in the control group resume clinic rehabilitation, and others continue home exercise for 6 weeks.
Clinic rehabilitation or home exercise with evaluation on the last day
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
J
Jianguang Sun
B
Baichuan He
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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