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Preliminary Study of taVNS for Stroke Recovery

This study is looking at how transcutaneous auricular vagus nerve stimulation (taVNS) using the Parasym Plus device might help people recover motor skills after a stroke. taVNS is a non-invasive way to stimulate the vagus nerve, which has shown promise in improving motor recovery in stroke patients. We are studying changes in brain activity (measured by EEG) and motor function (using the Fugl-Meyer Assessment - Upper extremity) before and after treatment. We are also collecting DNA data. You might be able to join if you are 18-80 years old, had your first stroke (ischemic or hemorrhagic) within the last month, and have motor impairments. We are looking for 44 participants. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 44 participants. It is not specified if it is randomized or blinded.
What's involved
You would have an EEG and Fugl-Meyer Assessment within 24 hours before and after the intervention. A DNA sample will be taken on Day 1 before treatment.
Compensation
Not stated in the trial record.
Follow-up
Your brain activity and motor function will be measured within 24 hours after the end of the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06226493

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

Recruiting
NAAges 18–80InterventionalTreatment
Casa Colina Hospital and Centers for Healthcare
~44 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Transcutaneous vagus nerve stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Resting state electroencephalogram (EEG)
Measured over within 24 hours before intervention and within 24 hours after the end of the intervention
+2 more outcomes measured

Conditions

Stroke

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Stroke

NCT06226493

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Casa Colina Hospital and Centers for Healthcare

    Pomona, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Elliott Block, MD · PRINCIPAL_INVESTIGATOR · Casa Colina Hospital and Centers for Healthcare

Who to contact

Caroline Schnakers, PhD
[email protected]
(909)596-7733 · ext. 3038
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Resting state electroencephalogram (EEG)within 24 hours before intervention and within 24 hours after the end of the intervention

    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.

  • Fugl-Meyer Assessment - Upper extremitywithin 24 hours before intervention and within 24hours after the end of the intervention

    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.

  • DNA DataSample to be taken at Day 1 of participation prior to taVNS treatment

    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.