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COMPLETED
NCT06288217
NA

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

Sponsor: NeuraStasis, Inc

View on ClinicalTrials.gov

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

Interventions

DEVICE

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

OTHER

Upper Limb Rehabilitation

Rehabilitation movements to improve upper limb function after stroke

OTHER

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