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

NCT ID: NCT06288217

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2024-12-31

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.

Detailed Description

This pilot study will proceed in two phases: Phase I, an unblinded blinded stage and Phase II, a blinded stage comparing intervention and sham groups.

Phase I will consist of 5 subjects, unblinded, receiving nTVNS. This phase will test the usability of the device and de-risk the use of nTVNS during rehabilitation. Visits will include consent and baseline evaluation followed by 6 weeks of treatment consisting of the standard of care with nTVNS. Rehabilitation and treatment will occur at a cadence of 3 sessions per week. Primary endpoints will be collected after 6 weeks.

Phase II will consist of a Prospective Randomized Open, Blinded Endpoint (PROBE) design. Subjects will be randomized to an intervention nTVNS group or a control sham stimulation group. The control sham stimulation consists of standard-of-care rehabilitation with only a minimal amount of nTVNS delivered at the start of each session during a tolerability assessment intended to support further blinding for therapists and subjects. The same evaluations, sessions, and endpoints will occur as those in Phase I.

Conditions

Stroke, Ischemic; Upper Extremity Paresis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Paired nTVNS Stimulation

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Upper Limb Rehabilitation

Intervention Type: OTHER

Rehabilitation movements to improve upper limb function after stroke

Sham Stimulation

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

Group Type: SHAM_COMPARATOR

Upper Limb Rehabilitation

Intervention Type: OTHER

Rehabilitation movements to improve upper limb function after stroke

Sham Stimulation

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DEVICE

Upper Limb Rehabilitation

Rehabilitation movements to improve upper limb function after stroke

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

nTVNS

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuraStasis, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Savitz, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Kirt Gill, MD

Role: STUDY_DIRECTOR

NeuraStasis, Inc

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kirt Gill, MD

Role: CONTACT

clinical@neurastasis.com

(832) 925-3302

Facility Contacts

Sean Savitz, MD

Role: primary

Sean.I.Savitz@uth.tmc.edu

713-500-7083

Emily Stevens, OTR

Role: backup

emily.a.stevens@uth.tmc.edu

713-500-7914

Other Identifiers

NS-CIP-001

Identifier Type: -

Identifier Source: org_study_id