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Rehabilitation Paired with VNS for Motor Function Recovery

NCT06892574 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-26

No results posted yet for this study

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 intracerebral hemorrhage (ICH).

Researchers will evaluate the efficacy and safety of VNS by comparing the improvements of arm motor function post-ICH in the active VNS combined rehabilitation group with that in the sham VNS combined rehabilitation group (actual intensity 0 mA).

Participants in this study will undergo a surgical procedure to implant the VNS system and will subsequently recieve a 6 weeks in-clinic therapy, followed by an additional 6 weeks home exercise. During the final 6 weeks, participants will either recieve in-clinic therapy or maintain their home exercise, depending on their assigned group.

Conditions

  • Spontaneous Intracerebral Hemorrhage
  • Motor Function
  • Upper Extremity Injury
  • Rehabilitation
  • Vagus Nerve Stimulation

Interventions

DEVICE

Active-VNS

A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve.

DEVICE

Sham VNS

A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA.

Sponsors & Collaborators

  • Beijing Pins Medical Co., Ltd

    collaborator INDUSTRY

  • First Affiliated Hospital of Fujian Medical University

    lead OTHER

Principal Investigators

  • Fuxin Lin · First Affiliated Hospital of Fujian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-03-31
Completion
2027-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06892574 on ClinicalTrials.gov