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

Description

This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial 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. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study.

Conditions

Stroke, Ischemic, Upper Extremity Paresis

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Study Overview

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Study Details

Study overview

This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial 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. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study.

Feasibility of Trigeminal and Vagus Nerve Stimulation in Subjects With Chronic Upper Extremity Deficits After Stroke

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

Condition
Stroke, Ischemic
Intervention / Treatment

-

Contacts and Locations

Houston

The University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NeuraStasis, Inc,

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

Kirt Gill, MD, STUDY_DIRECTOR, NeuraStasis, Inc

Study Record Dates

2024-12