MedTrace Logo

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

NCT06288217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-06-02

No results posted yet for this study

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.

Conditions

  • Upper Extremity Paresis
  • Stroke, Chronic

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.

Sponsors & Collaborators

  • NeuraStasis, Inc

    lead INDUSTRY

Principal Investigators

  • Sean Savitz, MD · The University of Texas Health Science Center, Houston

  • Kirt Gill, MD · NeuraStasis, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2025-11-13
Completion
2025-11-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06288217 on ClinicalTrials.gov