What is vagus nerve stimulation studying for ischemic stroke?

Vagus nerve stimulation (VNS) is being studied for improving arm movement after ischemic stroke. This trial evaluates if active VNS combined with rehabilitation improves motor function compared to sham VNS. The study is sponsored by Beijing Pins Medical Co., Ltd and aims to find new ways to help stroke survivors regain arm use.

Who may be eligible for this ischemic stroke clinical trial?

Adults aged 22 to 80 years with a history of unilateral ischemic stroke at least 9 months ago may be eligible. Participants must have weakness in one arm and be able to give consent and follow study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this ischemic stroke clinical trial?

Study-related care, including the implanted device, rehabilitation therapy, and all trial visits, is provided at no cost. However, personal travel and other expenses are not guaranteed to be covered and may vary.

Actively Recruiting

Phase Not Applicable

Age: 22Years - 80Years

All Genders

ID06722677

Study of Vagus Nerve Stimulation with Rehabilitation to Improve Arm Movement After Ischemic Stroke in Adults Aged 22 to 80

Led by Beijing Pins Medical Co., Ltd · Updated on 2024-12-10

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

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

Brief Title

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

Who Can Participate

Age: 22Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 22 years or older and less than 80 years, all genders accepted
History of unilateral supratentorial ischemic stroke 9 months or more but less than 10 years ago
Upper Extremity motor section of the Fugl-Meyer Assessment score between 20 and 50
Weakness on the right or left side of the upper extremity
Ability to understand, communicate, and give informed consent
Willingness and ability to comply with study visits after surgery

You will not qualify if you...

History of hemorrhagic stroke
Ongoing swallowing difficulties or aspiration problems
Previous injury to the vagus nerve on one or both sides
Use of medications that interfere with VNS effects on neurotransmitters during the study
Botox injections within 4 weeks prior to enrollment through the study end
Severe spasticity in the upper extremity (Modified Ashworth score 3 or higher)
Significant sensory loss in the upper extremity (Fugl-Meyer sensory score less than 6)
Severe depression (Beck Depression Scale score over 29)
Current or planned need for diathermy treatment
Use of other stimulation devices like pacemakers or neurostimulators
Pregnancy, breastfeeding, or plans to become pregnant during the study
Participation in another clinical trial within 3 months prior
Judged not suitable by the investigator

Research Team

Jianguang Sun

Baichuan He

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Study of Vagus Nerve Stimulation with Rehabilitation to Improve Arm Movement After Ischemic Stroke in Adults Aged 22 to 80

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria