Status:
RECRUITING
A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Conditions:
Ischemic Stroke
Upper Extremity Paresis
Eligibility:
All Genders
22-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
There are 6 follow-up timepoints in this trial: 1. Screening follow-up timepoint (V1): All participants will sign the informed consent form and receive pre-implant evaluation, including physical exam...
Eligibility Criteria
Inclusion 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. Subjects can follow trial commands.
- Subjects have good compliance and can complete the visits after surgery.
Exclusion Criteria:
- 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 as centrally acting cholinoceptor blockers, centrally acting adrenoceptor blockers, norepinephrine re-uptake inhibitors, etc.
- 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.
Key Trial Info
Start Date :
November 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06722677
Start Date
November 19 2024
End Date
November 1 2025
Last Update
December 10 2024
Active Locations (16)
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1
The First Affiliated Hospital of USTC
Hefei, Anhui, China, 230022
2
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
3
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China, 100039
4
The Xin Qiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China, 400037