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Not yet recruiting NCT06892574

Rehabilitation Paired with VNS for Motor Function Recovery

No phase Interventional Spontaneous Intracerebral Hemorrhage Motor Function Upper Extremity Injury Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active-VNS, Sham VNS.
Who it may be relevant to
Registry conditions: Spontaneous Intracerebral Hemorrhage, Motor Function, Upper Extremity Injury, Rehabilitation. Basic parameters: 22 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Trial of Rehabilitation Paired with VNS for Motor Function Recovery in Post-ICH Patients (Recovery Study)

Overview

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.

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.

Primary outcome measures

  • Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change [Time frame: V4, 6 weeks after baseline follow-up timepoint]
Secondary outcome measures (6)
  • Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Response [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint]
  • EQ-5D-3L Average Change [Time frame: 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]
  • Incidence of Adverse Events [Time frame: 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06892574 · 82371466

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗