Rehabilitation Paired with VNS for Motor Function Recovery

NCT ID: NCT06892574

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-12-30

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 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.

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 examination, brain magnetic resonance imaging, FMA-UE, WMFT, modified Ashworth scale, ect.

2. Surgery follow-up timepoint (V2): All participants will be implanted with the VNS system, including the G115R IPG and L312 lead.

3. Baseline follow-up timepoint (V3): There is a baseline evaluation 7 to 14 days after the surgery, then participants will be randomly assigned to VNS group or Control group.

4. Clinic rehabilitation follow-up timepoint (V4): Participants will receive standard clinic rehabilitation 3 days per week and lasting 6 weeks. Both active VNS group (VNS group) and sham VNS group (Control group) will receive rehabilitation. Participants will be evaluated at the last day of this follow-up timepoint.

5. Home exercise follow-up timepoint (V5): Participants will take standard home exercise everyday in 6 weeks. Both active VNS group (VNS group) and sham VNS group (Control group) will receive rehabilitation. At the last day, after evaluating, group assignment is unblinded.

6. Unmasking follow-up timepoint (V6): In this 6 weeks, all participants will receive active VNS. Participants in VNS group will still take standard home exercise, and participants in Control group will receive standard clinic rehabilitation again. Participants will be also evaluated at the last day of this follow-up timepoint.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VNS group

Active VNS paired with rehabilitation Device: VNS A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve.

Other: Rehabilitation Rehabilitation movements to improve upper limb function after stroke.

Group Type: EXPERIMENTAL

Active-VNS

Intervention Type: DEVICE

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

Control group

Sham VNS paired with rehabilitation Device: Sham VNS A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA.

Other: Rehabilitation Rehabilitation movements to improve upper limb function after stroke.

Group Type: SHAM_COMPARATOR

Sham VNS

Intervention Type: DEVICE

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

Interventions

Active-VNS

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

Intervention Type: DEVICE

Sham VNS

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role: collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

De-zhi Kang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fuxin Lin

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Central Contacts

Fuxin Lin

Role: CONTACT

lfxstudy@126.com

13600893154

Other Identifiers

82371466

Identifier Type: -

Identifier Source: org_study_id