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New treatment option for Ischemic Stroke
Official title A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)
ClinicalTrials.gov ID: NCT06722677
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join if
- Age ≥22 years and \<80 years, all gender is acceptable.
- History of unilateral supratentorial ischemic stroke ≥ 9 months but \< 10 years.
- Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50.
- Right- or left-sided weakness of upper extremity.
- Ability to communicate, understand, and give appropriate consent. people can follow trial commands.
You likely can't join if
- History of hemorrhagic stroke.
- Presence of ongoing dysphagia or aspiration difficulties.
- Prior injury to vagus nerve, either bilateral or unilateral.
- Subject receiving medication that may significantly interfere with actions of VNS on neurotransmitter systems at study entry, clinic rehabilitation...
- Botox injections within 4 weeks prior to enrollment through the unmasking follow-up timepoint (Visit 6).
- Severe spasticity of the upper extremity (Modified Ashworth ≥ 3).
See the full eligibility criteria
- Age ≥22 years and \<80 years, all gender is acceptable.
- History of unilateral supratentorial ischemic stroke ≥ 9 months but \< 10 years.
- Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50.
- Right- or left-sided weakness of upper extremity.
- Ability to communicate, understand, and give appropriate consent. people can follow trial commands.
- people have good compliance and can complete the visits after surgery.
- History of hemorrhagic stroke.
- Presence of ongoing dysphagia or aspiration difficulties.
- Prior injury to vagus nerve, either bilateral or unilateral.
- 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...
- Botox injections within 4 weeks prior to enrollment through the unmasking follow-up timepoint (Visit 6).
- Severe spasticity of the upper extremity (Modified Ashworth ≥ 3).
- Significant sensory loss of the upper extremity (Upper Extremity sensory section of the Fugl-Meyer Assessment score \< 6).
- Severe depression (Beck Depression Scale \> 29).
- Current requirement, or likely future requirement, of diathermy.
- Current use of any other stimulation device, such as a pacemaker or other neurostimulator.
- Pregnancy or plans to become pregnant or to breastfeed during the study period.
- Participated in any other clinical trials within the preceding 3 months.
- Not considered to be applicable by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.