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:

  1. Age ≥22 years and <80 years, all gender is acceptable.
  2. History of unilateral supratentorial ischemic stroke ≥ 9 months but < 10 years.
  3. Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50.
  4. Right- or left-sided weakness of upper extremity.
  5. Ability to communicate, understand, and give appropriate consent. Subjects can follow trial commands.
  6. Subjects have good compliance and can complete the visits after surgery.

Exclusion Criteria:

  1. History of hemorrhagic stroke.
  2. Presence of ongoing dysphagia or aspiration difficulties.
  3. Prior injury to vagus nerve, either bilateral or unilateral.
  4. 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.
  5. Botox injections within 4 weeks prior to enrollment through the unmasking follow-up timepoint (Visit 6).
  6. Severe spasticity of the upper extremity (Modified Ashworth ≥ 3).
  7. Significant sensory loss of the upper extremity (Upper Extremity sensory section of the Fugl-Meyer Assessment score < 6).
  8. Severe depression (Beck Depression Scale > 29).
  9. Current requirement, or likely future requirement, of diathermy.
  10. Current use of any other stimulation device, such as a pacemaker or other neurostimulator.
  11. Pregnancy or plans to become pregnant or to breastfeed during the study period.
  12. Participated in any other clinical trials within the preceding 3 months.
  13. 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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Page 1 of 4 (16 locations)

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