NCT06288217Completed
Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits
Feasibility of Trigeminal and Vagus Nerve Stimulation in Subjects With Chronic Upper Extremity Deficits After Stroke
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
This is a single-center, multiphase pilot study of 16 subjects with residual upper extremity deficits at least six months after a supratentorial ischemic or hemorrhagic stroke. The purpose of the study is to evaluate the clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Phase 1 consisted of 5 unblinded subjects receiving nTVNS to assess device usability and safety. Phase 2 used a Prospective Randomized Open, Blinded Endpoint (PROBE) design comparing nTVNS to sham stimulation in 11 subjects. The study will inform the design and implementation of a pivotal study.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 17 Feb 2024
- Start date
- 5 Mar 2024
- Primary completion date
- 13 Nov 2025
- Lead sponsor
- NeuraStasis, Inc
- Diseases
- Stroke
- NCT number
- NCT06288217
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 5 Mar 2024 to the primary completion date, 13 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Botox injections 12 weeks prior to or during therapy
- Participants who have had a craniectomy:
- Without replacement of bone flap
- With bone flap replaced \< 6 months prior to initiation of study activities
Other illness
- 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
- Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days
Other
- Participant with any implanted metallic device at or near the stimulation sites (forehead and ears).
- Participant with an implanted or active stimulator (ex. Deep brain stimulator, pacemaker, vagus nerve stimulator, defibrillator)
- Known or newly-discovered aneurysm or arteriovenous malformation
Who the study is looking for
- History of unilateral supratentorial ischemic, intracerebral hemorrhagic, subarachnoid hemorrhagic, or a heterogeneous lesion stroke that occurred at least 6 months but not more than 15 years prior to enrollment.
- Age \>30 years and \<85 years.
- Fugl-Meyer Assessment, Upper Limb (FMA-UE) baseline score of 10 to 56 (inclusive of 10 and 56).
- 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.
Age in the registry: 30 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.