Recruiting

taVNS

Sponsor:

Casa Colina Hospital and Centers for Healthcare

Code:

NCT06226493

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous vagus nerve stimulation

Study Details

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

Study ID

NCT06226493

Start date

Jan 29, 2024

Status verified date

Mar, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TaVNS intervention

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.

sham comparator: Sham Group

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).

Interventions

Transcutaneous vagus nerve stimulation

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.

Primary outcome measure

  • Resting state electroencephalogram (EEG) [ Time Frame: within 24 hours before intervention and within 24 hours after the end of the intervention ]
  • Fugl-Meyer Assessment - Upper extremity [ Time Frame: within 24 hours before intervention and within 24hours after the end of the intervention ]
  • DNA Data [ Time Frame: Sample to be taken at Day 1 of participation prior to taVNS treatment ]

Central Contacts and Locations

Central contacts

Caroline Schnakers, PhD

(909)596-7733cschnakers@casacolina.org

Niko Fullmer, BS

(909)596-7733nfullmer@casacolina.org

Locations

Casa Colina Hospital and Centers for Healthcare

Recruiting

Pomona, California, United States, 91769

Contacts

Caroline Schnakers, PhD

909-596-7733cschnakers@casacolina.org

Niko Fullmer

909-596-7733nfullmer@casacolina.org

More Information

Sponsor

Casa Colina Hospital and Centers for Healthcare

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • vagus nerve stimulation
  • electrophysiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Casa Colina Hospital and Centers for Healthcare on 2026-03-31.