Rehabilitation Paired with VNS for Motor Function Recovery

NCT06892574 | Not Yet Recruiting DMC

• 1 other identifier: 82371466
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Stroke; Hemorrhagic Stroke; Upper Extremity Paresis; Vagus Nerve Stimulation; Neuromodulation; Randomized Controlled Trial; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change

  The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment). The FMA-UE will be analyzed for difference in average change at Clinic rehabilitation follow-up timepoint compared to Baseline follow-up timepoint (Difference in average change in FMA-UE from V3 to V4).

  V4, 6 weeks after baseline follow-up timepoint

Secondary Outcomes (6)

• Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Response

  V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint

• Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change

  V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint

• Wolf Motor Function Test (WMFT) Average Change

  V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint

• Wolf Motor Function Test (WMFT) Response

  V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint

• EQ-5D-3L Average Change

  V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint

Study Arms (2)

VNS group

EXPERIMENTAL

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.

Device: Active-VNS

Control group

SHAM COMPARATOR

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.

Device: Sham VNS

Interventions

Active-VNS DEVICE

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

VNS group

Sham VNS DEVICE

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

Control group

Eligibility Criteria

• Age: 22 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead
• Beijing Pins Medical Co., Ltd: collaborator

MeSH Terms

Conditions

Arm Injuries; Stroke; Hemorrhagic Stroke; Paresis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fuxin Lin

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuxin Lin

CONTACT

13600893154; lfxstudy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The device can be set as active VNS or sham VNS (the actual intensity is 0 mA). An unmasking programmer not involved in treatments or assessments will be messaged the group of the participant and set appropriate stimulation setting at baseline follow-up timepoint. Other masking researchers, including therapists and assessors, as well as the participant will not know the stimulation setting.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-02