Status:
NOT_YET_RECRUITING
Rehabilitation Paired with VNS for Motor Function Recovery
Lead Sponsor:
First Affiliated Hospital of Fujian Medical University
Collaborating Sponsors:
Beijing Pins Medical Co., Ltd
Conditions:
Spontaneous Intracerebral Hemorrhage
Motor Function
Eligibility:
All Genders
22-79 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) combined with rehabilitation in improving upper extremity motor function after spontaneous in...
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
- Age ≥22 years and \<80 years, all gender is acceptable.
- History of unilateral supratentorial intracerebral hemorrhage ≥ 6 months but \< 5 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
- History of ischemic stroke.
- Cerebral hemorrhage resulting from tumors, trauma, aneurysms, or hemorrhagic transformation of ischemic 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).
- 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 :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06892574
Start Date
April 1 2025
End Date
December 30 2027
Last Update
March 26 2025
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