Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke.
Jesse Dawson, David Pierce, Anand Dixit...
https://pubmed.ncbi.nlm.nih.gov/26645257/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)
J
Jianguang Sun
B
Baichuan He
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Beijing Pins Medical Co., Ltd
Lead Sponsor
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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
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/19359643/Beijing Pins Medical Co., Ltd
Lead Sponsor