EEG Changes and DNA Markers Related to taVNS in Stroke Patients: a Preliminary Study

NCT06226493 | Recruiting FDA Device

• 1 other identifier: Casa Colina
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

In the United States, more than 795,000 people have a stroke every year. Motor impairment after a stroke is common and can be debilitating. To date, there remain few treatments available to help improve motor recovery after a stroke, making this an important area of research. Novel use of neuromodulation such as Invasive Vagus Nerve Stimulation (VNS) has been shown to improve motor recovery in stroke patients. Vagus nerve stimulation (VNS), in which the nerve is stimulated with electrical pulses, has demonstrated success for a variety of conditions, including inflammation, depression, cognitive dysfunction, chronic fatigue, headaches/migraines, pain, insomnia, and cardiovascular issues. Very recently, non-invasive options have been developed and might be a promising alternative. The research in this area is still very limited and much more research is needed to investigate non-invasive/trancutaneous auricular vagus nerve stimulation (taVNS) related biomechanisms and to further support its efficacy in acute patients. The purpose of this study is to build upon the current research to investigate changes in electrical brain activity (using electrophysiology) and genetic markers related to improvements in both motor and cognitive recovery following the use of taVNS vs. sham in acute stroke patients.

Conditions

Stroke

Keywords

vagus nerve stimulation; electrophysiology

Outcome Measures

Primary Outcomes (3)

• Resting state electroencephalogram (EEG)

  Resting state electroencephalogram (EEG) will be recorded with eyes open during 15 minutes using our 64 electrodes cap (actiCHamp Plus; brainproducts.com). Spectral analysis will be performed on consecutive, artifact-free, epochs of awake EEG signal. The selected epochs will be filtered (1-70 Hz, 12 db/octave), followed by a 60 Hz notch filter to suppress the noise of the electrical power line, reformatted against the linked Cz reference. In order to remove blink-artifacts, we will apply an ICA-artifact rejection algorithm. Then, the selected EEG activity will be divided into non-overlapping 2 s segments and analyzed using the fast Fourier transform. Power spectral density (PSD) will be evaluated in the delta (1-4 Hz), theta (5-8 Hz), alpha (9-12 Hz), and beta (13-30 Hz) bands. Primary measure will nevertheless be PSD ratio of fast (alpha) to slow (delta) frequencies. Such ratios will be compared just before starting and just after the last taVNS session.

  within 24 hours before intervention and within 24 hours after the end of the intervention

• Fugl-Meyer Assessment - Upper extremity

  Fugl-Meyer Assessment for Upper extremity evaluates and measures recovery in post-stroke hemiplegic patients. The motor portion scores range from 0-66. The higher the score, the better the function.

  within 24 hours before intervention and within 24hours after the end of the intervention

• DNA Data

  Frequency of polymorphisms per marker (BDNF,COMT) will be estimated. These values will be used as a cofactor in a repeated measures 2x2 ANOVA framework with behavioral data as dependent variable, time as a within-subjects variable (pre/post) and group (taVNS, Sham) as a between subjects variable.

  Sample to be taken at Day 1 of participation prior to taVNS treatment

Secondary Outcomes (2)

• The modified Rankin Scale

  within 24 hours before intervention as well as within 24 hours and 6 months after the end of the intervention

• The Montreal Cognitive Assessment

  within 24 hours before intervention as well as within 24 hours and 6 months after the end of the intervention

Study Arms (2)

TaVNS intervention

EXPERIMENTAL

Before starting applying taVNS, patients will be assessed using the FMA-U and the mRS for motor recovery as well as the MOCA for cognitive recovery. Resting state EEG will be recorded with eyes open during 15 minutes using our 64 electrodes cap (actiCHamp Plus; brainproducts.com), just after the behavioral assessment is performed. On the same day, patients will receive taVNS for 45 minutes, during therapy. The stimulation parameters, will be as follows: 250ms square pulses at 20 Hz. The electrical stimulation will given for 45 minutes a day for 10 working days (5 days a week for 2 weeks). The amplitude will be 1.7mA but may be reduced to 1.0mA if the patient is unable to tolerate due to discomfort or pain. After the last taVNS session is applied, outcome measures will be administered again by the research team. A follow-up at 6 months after the end of the last session will be conducted over the phone using the adapted version of the mRS and the MOCA.

Device: Transcutaneous vagus nerve stimulation

Sham Group

SHAM COMPARATOR

The sham procedure is identical to taVNS, except the device built-in sham setting will stop the stimulation gradually after one minute (this setting will be set by the research coordinator before starting the first session).

Device: Transcutaneous vagus nerve stimulation

Interventions

Transcutaneous vagus nerve stimulation DEVICE

The Parasym Plus device (https://parasym.io) is a transcutaneous auricular vagus nerve stimulator that has been deemed non-significant risk (NSR) by the FDA. Transcutaneous auricular vagus nerve stimulator is a non-significant risk device, as it involves electrical stimulation of the external ear using an ear clip, with no invasive components. The stimulation parameters will be limited to the confines of existing published data. tVNS is safe and well tolerated at doses tested in research studies. The Parasym device is considered low risk when used in accordance with the instructions for use. Participants will be properly trained to use the device, and those with contraindications will be excluded for extra precaution. A low incidence of skin irritation has been reported. No serious adverse events have been reported.

Sham Group; TaVNS intervention

Eligibility Criteria

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

You may qualify if:

• First-time Cerebrovascular Accident (Ischemic or Hemorrhagic)
• Within a month post-injury
• Presence of motor impairments (FMA-U≤62)

You may not qualify if:

• Advanced cardiac, pulmonary, liver, or kidney disease
• Bradycardia (Resting HR \< 60)
• Presence of Apraxia, Aphasia or confusion
• Other musculoskeletal or neurologic diseases that could interfere with the outcome measures
• Previous surgical intervention on the vagus nerve
• Participation in other clinical trials
• Alcohol or drug abuse

Sponsors & Collaborators

• Casa Colina Hospital and Centers for Healthcare: lead
• Foundation for Physical Medicine and Rehabilitation: collaborator

Study Sites (1)

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91769, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elliott Block, MD

  Casa Colina Hospital and Centers for Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Schnakers, PhD

CONTACT

(909)596-7733; cschnakers@casacolina.org

Niko Fullmer, BS

CONTACT

(909)596-7733; nfullmer@casacolina.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director of Research

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 26, 2024
• Study Start: January 29, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)