Clinical trial NCT04534556: Wireless Nerve Stimulation Device To Enhance Recovery After Stroke
Official title: Wireless Nerve Stimulation Device To Enhance Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Chronic Stroke
Upper Extremity Paresis
Ischemic Stroke
Hemorrhagic Stroke
Keywords: Vagus Nerve Stimulation (VNS)
Rehabilitation
Targeted Plasticity Therapy
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: The University of Texas at Dallas
name: University of Texas Southwestern Medical Center
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2020-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, double blind, randomized placebo controlled, plus open-label extension
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events [Device Safety]
timeFrame: From Week 1 through study follow-up, approximately two years after the final session of rehabilitation
Secondary outcomes:
measure: ReStore Stimulation Successes
timeFrame: Weeks 6-11
measure: Upper-Extremity Fugl-Meyer Assessment (UEFM)
timeFrame: Weeks 1, 5, 12, 19, 20, 24, 32
measure: Wolf Motor Task Functional Ability Scale
timeFrame: Weeks 1, 5, 12, 19, 20, 24, 32
measure: Action Research Arm Test
timeFrame: Weeks 1, 5, 12, 19, 20, 24, 32
measure: Modified Rankin Scale
timeFrame: Weeks 1, 5, 12, 19, 20, 24, 32
measure: Quantitative Force and Range of Motion Assessment
timeFrame: Weeks 1, 5-20, 24, 32
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation
state: Texas
Study officials:
affiliation: University of Texas at Dallas
name: Michael Kilgard, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Dallas
name: Robert Rennaker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Dallas
name: Seth Hays, PhD
role: STUDY_DIRECTOR
affiliation: University of Texas Southwestern Medical Center
name: Jane Wigginton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor Scott & White Institute for Rehabilitation
name: Rita Hamilton, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor Health Care System
name: Michael Foreman, MD, FACS
role: STUDY_DIRECTOR
affiliation: Baylor Health Care System
name: Richard Naftalis, MD, FAANS, FACS
role: STUDY_DIRECTOR
affiliation: Baylor Health Care System
name: Mark Powers, PhD
role: STUDY_DIRECTOR
affiliation: Baylor Health Care System
name: Ann Marie Warren, PhD
role: STUDY_DIRECTOR
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