Non-invasive nerve stimulation for stroke recovery
Feasibility of Trigeminal and Vagus Nerve Stimulation in Subjects With Chronic Upper Extremity Deficits After Stroke
This study is testing if a new non-invasive nerve stimulation treatment can help stroke patients with arm problems recover better during rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | NeuraStasis, Inc Industry-sponsored |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06288217 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and effectiveness of non-invasive electrical stimulation of the trigeminal and vagus nerves in stroke patients with chronic upper extremity deficits. It involves two phases: an initial unblinded phase with five subjects to assess device usability, followed by a randomized, blinded phase comparing the stimulation intervention to a control sham group. Participants will undergo rehabilitation sessions three times a week for six weeks, with primary endpoints assessed at the end of the treatment period.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 80 who have experienced a unilateral ischemic stroke at least six months prior and have specific upper limb deficits.
Not a fit: Patients with implanted devices in the head or neck, or those with advanced organ dysfunction, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery of upper limb function in stroke survivors.
How similar studies have performed: While this approach is innovative, similar studies on nerve stimulation have shown promise in improving recovery outcomes in stroke patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sean Savitz, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Kirt Gill, MD
- Email: clinical@neurastasis.com
- Phone: (832) 925-3302
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.