Wireless nerve stimulation to improve recovery after stroke
Wireless Nerve Stimulation Device To Enhance Recovery After Stroke
This study is testing a new wireless device that uses nerve stimulation during rehab exercises to see if it helps stroke survivors recover better and regain movement and feeling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 22 Years to 79 Years |
| Sex | All |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04534556 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel approach using wireless vagus nerve stimulation (VNS) to enhance recovery of motor and sensory functions in individuals who have experienced a stroke. The technique, known as targeted plasticity therapy (TPT), involves delivering brief pulses of VNS during rehabilitation exercises to activate neural circuits that promote recovery. Previous research has shown that pairing VNS with rehabilitation can improve outcomes in various neurological injuries, including stroke. This trial aims to further evaluate the effectiveness and safety of this new device in enhancing recovery after stroke.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22-79 who have experienced an ischemic or hemorrhagic stroke at least 12 months prior and have specific motor function scores indicating upper extremity paresis.
Not a fit: Patients with severe spasticity or significant language or attention deficits that interfere with participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor recovery and quality of life for stroke survivors.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- Baylor Scott & White Institute for Rehabilitation — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Michael Kilgard, PhD — University of Texas at Dallas
- Study coordinator: Alvaro Carrera
- Email: alvaro.carrera@bswhealth.org
- Phone: 469-831-5321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.