RECRUITING

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

Conditions

Stroke, Ischemic Upper Extremity Paresis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-05

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06288217

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.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Kirt Gill, MD

CONTACT

(832) 925-3302

clinical@neurastasis.com

Principal Investigator

Sean Savitz, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Kirt Gill, MD

STUDY_DIRECTOR

NeuraStasis, Inc

Study Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-05

Study Completion Date2024-12

Study Record Updates

Study Start Date2024-03-05

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Stroke, Ischemic
Upper Extremity Paresis