Vestibular Perception Gates Autonomic Responses to Sinusoidal Galvanic Vestibular Stimulation

NCT07715227 | Completed

• 3 other identifiers: IRB A343BR27198099IRB-A843
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

Brief Summary This randomized, double-blind, sham-controlled clinical trial is designed to investigate whether repeated sinusoidal galvanic vestibular stimulation (GVS) influences cardiac autonomic regulation in healthy adults during their routine occupational activities, and to determine whether these effects depend on subjective vestibular perception (dizziness) experienced during stimulation. The main questions it aims to answer are: Does repeated sinusoidal GVS alter heart rate variability (HRV) in healthy adults during their normal work activities? Do autonomic responses to GVS depend on the subjective intensity of dizziness experienced during stimulation? Does repeated GVS affect psycho-emotional well-being, including depressive and anxiety symptoms? Researchers will compare active GVS to sham stimulation to see if active stimulation produces measurable changes in cardiac autonomic regulation and whether these changes differ between participants reporting stronger versus minimal dizziness. Participants will undergo baseline assessment, complete four consecutive daily sessions of active or sham GVS, and undergo post-intervention assessment. Autonomic responses will be assessed using multiple HRV indices.

Conditions

Healthy Volunteers

Keywords

galvanic vestibular stimulation; heart rate variability; vestibulo-autonomic coupling; vestibular perception; autonomic regulation; interoception; occupational health; ecological validity

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate Variability (HRV) Indices from Baseline to Post-Course and During Acute Stimulation

  HRV will be assessed using complementary indices derived from continuous ambulatory ECG recordings (Polar H10) across multiple temporal scales: (1) course-level: baseline vs. post-course comparison; (2) acute: pre-stimulation, during stimulation, and post-stimulation epochs; (3) macro-scale: one-hour pre-stimulation vs. one-hour post-stimulation windows. Indices include time-domain (SDNN, mean RR intervals), frequency-domain (HFnu), nonlinear (SD1, SD2, SD2/SD1 ratio, DFA α1), and geometric (Baevsky Stress Index) measures.

  • Baseline (Day 1) • Days 2-5 (pre-stimulation, during 6-minute stimulation, immediately post-stimulation, and 1 hour post-stimulation) • Day 6 (post-course assessment)

Secondary Outcomes (5)

• Autonomic Responses by Vestibular Perception Subgroups (High vs Low/No Dizziness)

  • Baseline (Day 1) • Days 2-5 (pre-stimulation, during 6-minute stimulation, immediately post-stimulation, and 1 hour post-stimulation) • Day 6 (post-course assessment)

• Stimulation-Related Sensations and Tolerability

  • Days 2-5 (immediately after each stimulation session)

• Changes in Psycho-Emotional Well-Being (Depressive Symptoms, Anxiety, and Affect)

  • Baseline (Day 1) • Day 6 (post-course assessment)

• Blinding Integrity Assessment

  • Day 5 (immediately after the fourth stimulation session)

• Change in Positive and Negative Affect as Measured by the PANAS

  • Days 2-5 (morning, pre-stimulation, post-stimulation, and end of workday)

Study Arms (2)

Active GVS

EXPERIMENTAL

Participants receive active sinusoidal galvanic vestibular stimulation (GVS) using the BrainPatch device. Stimulation parameters: 0.1 Hz sinusoidal waveform, peak current 0.62 mA, delivered for 6 minutes through bilateral electrodes placed over the mastoid processes. Participants remain seated with eyes closed while listening to relaxing meditative music. Stimulation is administered once daily for four consecutive days.

Device: Galvanic Vestibular Stimulation (GVS) using BrainPatch device

Sham GVS

SHAM COMPARATOR

An identical acoustic environment was created in the Sham group. To ensure effective blinding, participants in the Sham group received only one 10-second stimulation cycle at the beginning of the 6-minute session.

Device: Galvanic Vestibular Stimulation (GVS) using BrainPatch device

Interventions

Galvanic Vestibular Stimulation (GVS) using BrainPatch device DEVICE

Sinusoidal galvanic vestibular stimulation delivered via bilateral mastoid electrodes using the portable BrainPatch device. Stimulation parameters: 0.1 Hz sinusoidal waveform, peak current 0.62 mA, administered for 6 minutes per session with participants seated, eyes closed, and listening to relaxing meditative music.

Also known as: GVS

Active GVS; Sham GVS

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Аge between 18 and 49 years
• Absence of dermatological conditions (e.g., eczema, psoriasis) or open wounds in the electrode placement area (mastoid region)
• No metallic or electronic implants (e.g., pacemakers, cochlear implants)
• No history of neurological, psychiatric, or cardiovascular disorders
• Not currently pregnant
• Employment or activities not involving the operation of vehicles or hazardous machinery

Sponsors & Collaborators

• Al-Farabi Kazakh National University: lead
• Research and Production Center "Comprehensive Equipment": collaborator
• BrainPatch: collaborator

Study Sites (2)

JSC "Kazakhtelecom"

Almaty, 050004, Kazakhstan

Location

Al-Farabi Kazakh National University

Almaty, 050040, Kazakhstan

Location

Related Publications (11)

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  PMID: 39606706 BACKGROUND

• Pliego A, Vega R, Gomez R, Reyes-Lagos JJ, Soto E. A transient decrease in heart rate with unilateral and bilateral galvanic vestibular stimulation in healthy humans. Eur J Neurosci. 2021 Jul;54(2):4670-4681. doi: 10.1111/ejn.15338. Epub 2021 Jun 22.

  PMID: 34076918 BACKGROUND

• Thayer JF, Lane RD. A model of neurovisceral integration in emotion regulation and dysregulation. J Affect Disord. 2000 Dec;61(3):201-16. doi: 10.1016/s0165-0327(00)00338-4.

  PMID: 11163422 BACKGROUND

• Matsugi A, Nagino K, Shiozaki T, Okada Y, Mori N, Nakamura J, Douchi S, Oku K, Nagano K, Tamaru Y. No Impact of Stochastic Galvanic Vestibular Stimulation on Arterial Pressure and Heart Rate Variability in the Elderly Population. Front Hum Neurosci. 2021 Feb 17;15:646127. doi: 10.3389/fnhum.2021.646127. eCollection 2021.

  PMID: 33679355 BACKGROUND

• Yamamoto Y, Struzik ZR, Soma R, Ohashi K, Kwak S. Noisy vestibular stimulation improves autonomic and motor responsiveness in central neurodegenerative disorders. Ann Neurol. 2005 Aug;58(2):175-81. doi: 10.1002/ana.20574.

  PMID: 16049932 BACKGROUND

• Craig AD. How do you feel--now? The anterior insula and human awareness. Nat Rev Neurosci. 2009 Jan;10(1):59-70. doi: 10.1038/nrn2555.

  PMID: 19096369 BACKGROUND

• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

  PMID: 29034226 BACKGROUND

• Yates BJ, Bolton PS, Macefield VG. Vestibulo-sympathetic responses. Compr Physiol. 2014 Apr;4(2):851-87. doi: 10.1002/cphy.c130041.

  PMID: 24715571 BACKGROUND

• Marchand S, Langlade A, Legois Q, Severac Cauquil A. A wide-ranging review of galvanic vestibular stimulation: from its genesis to basic science and clinical applications. Exp Brain Res. 2025 Apr 27;243(5):131. doi: 10.1007/s00221-025-07079-8.

  PMID: 40289049 BACKGROUND

• Dlugaiczyk J, Gensberger KD, Straka H. Galvanic vestibular stimulation: from basic concepts to clinical applications. J Neurophysiol. 2019 Jun 1;121(6):2237-2255. doi: 10.1152/jn.00035.2019. Epub 2019 Apr 17.

  PMID: 30995162 BACKGROUND

• Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.

  PMID: 8737210 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 20, 2026
• Study Start: November 30, 2021
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data and supporting documents will be available beginning 9 months following publication of the main results and ending 5 years after publication.
• Access Criteria: Data and supporting documents will be made available upon reasonable request to the principal investigator. Requests will be reviewed to ensure appropriate use and compliance with ethical standards.

Locations

KA (2)