Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

Launched by BAYLOR RESEARCH INSTITUTE · Aug 31, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new device that uses a technique called targeted plasticity therapy (TPT) to help improve movement and feeling in the arms and hands of people who have had a stroke. The device sends brief pulses of stimulation to the vagus nerve, which may help the brain recover better during rehabilitation exercises. Previous studies have shown that this method can be safe and effective for enhancing recovery after strokes and other neurological injuries.

To be eligible for this trial, participants must be adults aged 22 to 79 who experienced a stroke at least a year ago and have some difficulty moving their arms or hands. They should be willing to follow the study procedures and be available for follow-up visits. Participants can expect to receive the nerve stimulation along with rehabilitation exercises, and the study aims to determine if this approach is safe and helpful for improving their recovery. It’s important to note that certain medical conditions or treatments might prevent someone from participating, so a thorough evaluation will be done before enrollment.

Gender

ALL

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