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Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits
Sponsor: NeuraStasis, Inc
Summary
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.
Official title: Feasibility of Trigeminal and Vagus Nerve Stimulation in Subjects With Chronic Upper Extremity Deficits After Stroke
Key Details
Gender
All
Age Range
30 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2024-03-05
Completion Date
2025-11-13
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation)
Pulsed electrical stimulation of the trigeminal and vagus nerves paired with upper limb rehabilitation movements
Upper Limb Rehabilitation
Rehabilitation movements to improve upper limb function after stroke
Sham Stimulation
Control sham stimulation of the trigeminal and vagus nerves is delivered at the start of each session. Performed alongside standard-of-care rehabilitation.
Locations (1)
The University of Texas Health Science Center at Houston
Houston, Texas, United States