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

NCT06288217 | Recruiting FDA Device

• 1 other identifier: NS-CIP-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change

  The Fugl-Meyer Assessment, Upper Limb (FMA-UE) will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).

  Within 7 days of completing 6 weeks of rehabilitation

Secondary Outcomes (8)

• Action Research Arm Test (ARAT) Average Change

  Within 7 days of completing 6 weeks of rehabilitation

• Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response %

  Within 7 days of completing 6 weeks of rehabilitation

• Proportion of subjects completing all pre-specified treatment doses

  Upon completion of 6 weeks of rehabilitation

• Subject Questionnaire on Device Usage

  Upon completion of 6 weeks of rehabilitation

• Therapist Questionnaire on Device Usage

  Upon completion of 6 weeks of rehabilitation

Study Arms (2)

Paired nTVNS Stimulation

EXPERIMENTAL

Non-invasive electrical stimulation of the trigeminal and vagus nerves will be delivered by the NeuraStasis Stimulator System. The non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear). The operator controls the stimulation delivery through the accompanying Controller. Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. A 15-minute priming stimulation is delivered next, followed by the standard of care rehabilitation over the remaining session. During this rehabilitation paired nTVNS is delivered with repetitive motions.

Device: NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation); Other: Upper Limb Rehabilitation

Sham Stimulation

SHAM COMPARATOR

For the active shame comparator group, the non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear) as in the experimental group. The operator controls the stimulation delivery through the accompanying Controller. Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. A sham stimulation dosage will follow for the remaining procedure, including the priming stimulation, period and the standard of care rehabilitation

Other: Upper Limb Rehabilitation; Other: Sham Stimulation

Interventions

NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) DEVICE

Pulsed electrical stimulation of the trigeminal and vagus nerves paired with upper limb rehabilitation movements

Also known as: nTVNS

Paired nTVNS Stimulation

Upper Limb Rehabilitation OTHER

Rehabilitation movements to improve upper limb function after stroke

Paired nTVNS Stimulation; Sham Stimulation

Sham Stimulation OTHER

Control sham stimulation of the trigeminal and vagus nerves is delivered at the start of each session. Performed alongside standard-of-care rehabilitation.

Sham Stimulation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuraStasis, Inc: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Paresis

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Sean Savitz, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Kirt Gill, MD

  NeuraStasis, Inc

  STUDY DIRECTOR

Central Study Contacts

Kirt Gill, MD

CONTACT

(832) 925-3302; clinical@neurastasis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: March 1, 2024
• Study Start: March 5, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)