Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits

Launched by NEURASTASIS, INC · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for individuals who have difficulty using their arm or hand after experiencing a stroke. Specifically, it looks at the effects of a non-invasive device that stimulates certain nerves in the head and neck to see if it can help improve movement in the upper arm and hand. The study will involve up to 25 participants who had a stroke at least six months ago and are between 40 and 80 years old. Participants will either receive the actual treatment or a placebo (which does not provide any real treatment) while continuing their regular rehabilitation.

To be eligible for this study, participants must have had a specific type of stroke and currently have some weakness in one arm. They should be able to follow simple instructions and communicate effectively. Participants will not be able to join if they have certain medical devices, skin issues in the treatment area, or other serious health concerns. This pilot study aims to gather information about the safety and effectiveness of the treatment, which will help shape future studies. If you or a loved one is interested in participating, it could be an opportunity to contribute to new ways to support recovery after a stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • History of unilateral supratentorial ischemic stroke that occurred at least 6 months but not more than 10 years prior to enrollment.
• • Age \>40 years and \<80 years.
• • Fugl-Meyer Assessment, Upper Limb (FMA-UE) baseline score of 20 to 50 (inclusive of 20 and 50).
• • Ability to communicate, understand, and provide appropriate consent. Subjects should be able to follow two-step commands.
• • Right- or left-sided weakness of the upper extremity.
• • Exclusion Criteria
• • Participant has implanted metallic or electronic devices in the head or neck
• • Hemorrhagic stroke or a heterogenous lesion etiology
• • Participant has a cardiac pacemaker or implanted or wearable defibrillator
• • Participant skin in the stimulation area has open wounds, skin eruptions, swollen, infected, or inflamed areas, or skin abnormalities that could be cancerous
• • Advanced cardiac, pulmonary, liver, kidney dysfunction or blood system disease
• • Participant has a fever or shows clinical signs concerning for an infectious disease
• • Other neurologic or musculoskeletal diseases that could interfere with the assessments of this study
• • Low heart rate (\<60 bpm) from a cardiac conduction block or related etiology
• • Participant has a history of trigeminal neuralgia
• • Participant has a history of Bell's Palsy
• • History of cranial nerve neuropathy (including facial nerve injury), carotid surgery, vagotomy, or other surgical intervention on the vagus nerve
• • History of recurrent syncopal events
• • Known or newly-discovered aneurysm or arteriovenous malformation
• • Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days
• • Botox injections 12 weeks prior to or during therapy