Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

September 12, 2023 updated by: Baylor Research Institute
Texas Biomedical Device Center (TxBDC) has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Preclinical findings demonstrate that VNS paired with rehabilitative training enhances recovery in multiple models of neurological injury, including stroke, spinal cord injury, intracerebral hemorrhage, and traumatic brain injury. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, two initial studies and a recently completed Phase 3 clinical trial using a commercially available device demonstrates that paired VNS with rehabilitation is safe and improves motor recovery after stroke. The purpose of this study is to extend these findings and evaluate whether VNS delivered with the new device paired with rehabilitation represents a safe and feasible strategy to improve recovery of motor and sensory function in participants with stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott & White Institute for Rehabilitation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Adult, aged 22-79
  • Ischemic or hemorrhagic stroke that occurred ≥ 12 months prior to enrollment
  • UEFM score of 20 to 50
  • Modified Rankin Score of 2, 3, or 4
  • Right vocal cord has normal movement when assessed by laryngoscopy
  • Women of reproductive potential must use contraceptive protection
  • Meets all clinical criteria for the surgical VNS implantation as determined by the PI, surgeon, and anesthesiologist

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Deficits in language or attention that interfere with study participation
  • Severe spasticity (Modified Ashworth ≥ 3)
  • Medical or mental instability that would likely interfere with study protocol
  • Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.)
  • Presence of any other implanted electrical stimulation device
  • Prior injury to vagus nerve
  • Lactating, pregnant, or plan to become pregnant
  • Participation in another interventional clinical trial
  • Clinical complications that hinder or contraindicate the surgical procedure
  • Abusive use of alcohol and/or illegal substances use
  • Participants with sickle cell, lupus, clotting disorders or active neoplastic disease.
  • Participants with any any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator.
  • Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
  • Recent history of syncope
  • Recent history of dysphagia
  • Current or anticipated requirement for diathermy
  • Uncontrolled hypertension
  • Diagnosed with Cerebral amyloid angiopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Start Vagus Nerve Stimulation group
The Immediate Start VNS group will receive rehabilitation and active stimulation for 18 in-office sessions over the course of approximately six weeks during Phase 1. For Phase 2, all subjects will be provided with the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately six weeks. Additionally, participants may be provided with a system of rehabilitative devices to utilize at home.
Device: Active Vagus Nerve Stimulation
Stimulation of the vagus nerve that is paired with upper limb rehabilitation. VNS stimulation as described in the current study consists of 0.5 second trains of 0.8 mA; 100 µsec biphasic pulses at 30 Hz. Stimulation trains are delivered only during rehabilitation.
Other Names:
  • VNS
  • vagus nerve stimulation
  • paired VNS
Placebo Comparator: Delayed Start Vagus Nerve Stimulation group
The Delayed Start VNS group will receive equivalent rehabilitation with placebo stimulation for 18 in-office sessions over the course of approximately six weeks during Phase 1. For Phase 2, all subjects will be provided with the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately six weeks. Additionally, participants may be provided with a system of rehabilitative devices to utilize at home.
Device: Placebo Vagus Nerve Stimulation
During Phase 1 of the study, the placebo group will receive a minimal amount of stimulation that fails to sufficiently activate the nerve, unknown to the participant and therapists. All participants will receive active stimulation during the Phase 2 open-label portion of the study.
Other Names:
  • placebo
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events [Device Safety]
Time Frame: From Week 1 through study follow-up, approximately two years after the final session of rehabilitation
Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore system and provide a better understanding of risk/benefit analysis
From Week 1 through study follow-up, approximately two years after the final session of rehabilitation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ReStore Stimulation Successes
Time Frame: Weeks 6-11
The percentage of stimulation attempts classified as 'Success' from the total number of stimulation attempts made will be calculated for each participant and the mean percent of successful attempts across all participants will be used as the outcome measure.
Weeks 6-11
Upper-Extremity Fugl-Meyer Assessment (UEFM)
Time Frame: Weeks 1, 5, 12, 19, 20, 24, 32
The UEFM Assessment is a sixty-six point assessment of mobility administered by a therapist designed to facilitate consistent collection and reporting of basic upper extremity findings. The endpoint will be: estimate the shift in UEFM assessment following active VNS
Weeks 1, 5, 12, 19, 20, 24, 32
Wolf Motor Task Functional Ability Scale
Time Frame: Weeks 1, 5, 12, 19, 20, 24, 32
The Wolf Motor Task Functional Ability Scale (WMFT-FAS) is a quantitative measure of upper extremity motor ability through timed and functional tasks. The task includes evaluation of dexterity, strength, and upper extremity function. Functional ability is measured on a 6-point ordinal scale (0-5) with a maximum total score of 75. The endpoint will be: estimate the shift in WMFT-FAS assessment following active VNS
Weeks 1, 5, 12, 19, 20, 24, 32
Action Research Arm Test
Time Frame: Weeks 1, 5, 12, 19, 20, 24, 32
The ARAT is a nineteen-item observational assessment of upper limb function. The areas of assessment include activities of daily living, coordination, dexterity, and upper extremity function. The endpoint will be: Estimate the shift in ARAT assessment following active VNS
Weeks 1, 5, 12, 19, 20, 24, 32
Modified Rankin Scale
Time Frame: Weeks 1, 5, 12, 19, 20, 24, 32
The Modified Rankin Scale (MRS) is a single item global outcomes rating scale that categorizes level of functional independence. The measure reflects ability to perform activities of daily living and functional mobility. The MRS is a 6 point scale with 0 being no disability and 5 being severe disability. A score of 6 indicates that the patient has expired. The endpoint will be: Estimate the shift in MRS assessment following active VNS
Weeks 1, 5, 12, 19, 20, 24, 32
Quantitative Force and Range of Motion Assessment
Time Frame: Weeks 1, 5-20, 24, 32
The Quantitative Force and Range of Motion Assessment form is a physical assessment of upper limb changes in force/torque as a result of VNS paired rehabilitation. The endpoints will be: 10% increase in finger pinch and flexion force following active VNS; 10% increase in wrist flexion and extension force following active VNS; 10% increase in wrist pronation and supination force following active VNS
Weeks 1, 5-20, 24, 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
University of Texas Southwestern Medical Center
The University of Texas at Dallas

Investigators

  • Principal Investigator: Michael Kilgard, PhD, University of Texas at Dallas
  • Principal Investigator: Robert Rennaker, PhD, University of Texas at Dallas
  • Study Director: Seth Hays, PhD, University of Texas at Dallas
  • Principal Investigator: Jane Wigginton, MD, University of Texas Southwestern Medical Center
  • Study Director: Mark Powers, PhD, Baylor Health Care System
  • Study Director: Richard Naftalis, MD, FAANS, FACS, Baylor Health Care System
  • Study Director: Ann Marie Warren, PhD, Baylor Health Care System
  • Principal Investigator: Rita Hamilton, DO, Baylor Scott & White Institute for Rehabilitation
  • Study Director: Michael Foreman, MD, FACS, Baylor Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020-392
  • UG3NS109497 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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