Healthy VolunteersGVS-HRVNCT07715227
Vestibular Perception Gates Autonomic Responses to Sinusoidal Galvanic Vestibular Stimulation
A study testing Galvanic Vestibular Stimulation (GVS) using BrainPatch device in people with Healthy Volunteers, run by Al-Farabi Kazakh National University at 2 sites in Kazakhstan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Galvanic Vestibular Stimulation (GVS) using BrainPatch device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 30 Nov 2021to 13 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Failure to meet any of the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Kazakhstan2 sites
JSC "Kazakhtelecom"
Almaty, 050004
Al-Farabi Kazakh National University
Almaty, 050040
About this study
Official title: Effects of Galvanic Vestibular Stimulation on Heart Rate Variability
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:
Read more
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.
Read the detailed description
Detailed Description
Scientific Background and Rationale Occupational stress is recognized as an important contributor to impaired physical and mental health. Continuous exposure to cognitive workload, emotional demands, and psychosocial stressors may alter autonomic nervous system regulation, resulting in reduced physiological adaptability and increased cardiovascular risk. Heart rate variability (HRV) is one of the most widely accepted non-invasive indicators of autonomic regulation, reflecting the dynamic interaction between sympathetic and parasympathetic branches. Reduced HRV has consistently been associated with impaired stress resilience, diminished vagal regulation, increased cardiovascular morbidity, and adverse mental health outcomes.
Galvanic vestibular stimulation (GVS) applies weak electrical currents through electrodes positioned over the mastoid processes behind the ears. The electrical current activates vestibular afferents, influencing vestibular pathways that project not only to cortical vestibular regions but also to autonomic nuclei within the brainstem. Experimental and neuroanatomical studies have demonstrated direct vestibulo-autonomic connections involving the vestibular nuclei, nucleus tractus solitarius, dorsal motor nucleus of the vagus nerve, and other cardiovascular regulatory centers. Through these pathways, vestibular stimulation may influence autonomic cardiovascular regulation and HRV.
Several laboratory studies have reported that GVS may increase parasympathetic activity, reduce sympathetic influence, and modify cardiovascular reflexes. However, reported autonomic effects vary considerably across studies due to differences in stimulation parameters, waveforms, current intensity, recording conditions, and participant characteristics. Most previous investigations were conducted under highly controlled laboratory conditions, which maximize internal validity but limit ecological validity and clinical translation.
Recent technological advances have facilitated the development of portable GVS systems suitable for ambulatory use. These developments have created opportunities to evaluate vestibular neuromodulation under real-life conditions, where autonomic regulation is continuously challenged by natural fluctuations in cognitive workload, emotional demands, posture, movement, fatigue, and environmental stressors. Despite increasing interest in wearable neuromodulation technologies, the physiological effects of repeated GVS administered during normal occupational activities remain insufficiently investigated.
An additional unresolved question concerns the considerable inter-individual variability in subjective responses to vestibular stimulation. Some individuals experience pronounced sensations of self-motion or dizziness during GVS, whereas others report minimal or no vestibular sensations despite receiving identical stimulation parameters. This variability suggests that autonomic responses may depend not only on the physical characteristics of vestibular stimulation but also on the degree of conscious vestibular perception.
Current concepts of interoception and predictive processing propose that autonomic regulation is dynamically influenced by the brain's interpretation of incoming bodily signals rather than by peripheral sensory input alone. According to these models, physiological responses may be modulated by the subjective significance of sensory information and by prediction errors generated when incoming vestibular information conflicts with visual and proprioceptive signals. Therefore, conscious perception of vestibular stimulation may represent an important determinant of autonomic adaptation.
Detailed Methodology The study was conducted in two occupational settings: rest facilities of Kazakhtelecom JSC and the neurocognitive laboratories of the Brain Institute at Farabi University.
Following enrollment and baseline assessment, participants entered a four-day intervention period with one study visit per day. Each visit followed an identical protocol. Upon arrival, participants were fitted with a Polar H10 chest-mounted heart rate sensor for continuous ambulatory ECG recording. After sensor placement, participants completed the first PANAS assessment. ECG recording continued while participants performed their routine occupational activities. Immediately before stimulation, participants completed a second PANAS assessment. They subsequently received either active or sham GVS while seated comfortably with their eyes closed, listening to standardized meditative music. Immediately following stimulation, participants completed a third PANAS assessment together with a standardized questionnaire evaluating stimulation-related sensations (dizziness, warmth, burning, itching, each rated on a 4-point scale from 0 = "not experienced" to 3 = "strongly experienced"). Approximately one hour after stimulation, the sensor was removed and participants completed the fourth PANAS assessment. On the final intervention day, participants indicated whether they believed they had received active or sham stimulation to evaluate blinding integrity.
One to two days after the intervention course, participants underwent a post-intervention assessment identical to baseline procedures, including ambulatory ECG monitoring and psychometric evaluation.
Heart Rate Variability Assessment Continuous RR interval data were acquired using the Polar H10 sensor. Recordings were exported for offline processing using Kubios HRV Premium software. Artifact correction and interpolation procedures were applied before HRV calculation. HRV indices were calculated for consecutive six-minute epochs according to international recommendations.
Time-domain indices included mean RR intervals and SDNN. Frequency-domain analysis included normalized high-frequency power (HFnu). Low-frequency power was excluded from primary analyses because the stimulation frequency (0.1 Hz) overlapped with the conventional low-frequency HRV band, potentially confounding physiological interpretation. Nonlinear indices included SD1, SD2, the SD2/SD1 ratio, and detrended fluctuation analysis (DFA α1). The Baevsky Stress Index was calculated as an integrative geometric measure of regulatory strain.
HRV was analyzed at three temporal scales: acute (six-minute epochs before, during, and after stimulation), macro-scale (one-hour pre- and post-stimulation recordings), and course-level (baseline versus post-intervention comparisons).
Psychometric Assessment Psycho-emotional functioning was evaluated using standardized self-report questionnaires. The Positive and Negative Affect Schedule (PANAS) was administered repeatedly to assess short-term affective changes. Depressive symptoms were evaluated using the Inventory of Depressive Symptomatology - Self Report (IDS-SR). Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Validated Russian-language versions were used for all questionnaires.
Statistical Analysis Baseline characteristics were compared using parametric or non-parametric tests depending on data distribution. Categorical variables were analyzed using Pearson's chi-square tests.
Psychometric outcomes were analyzed using repeated-measures ANOVA and ANCOVA with baseline adjustment when appropriate. Post hoc comparisons were corrected using Bonferroni adjustment.
Primary autonomic analyses were performed using linear mixed-effects models estimated by restricted maximum likelihood. Separate models were constructed for acute, macro-scale, and cumulative analyses. Mean heart rate was included as a time-varying covariate. Random intercepts were specified for individual participants, and first-order autoregressive covariance structures were applied to model temporal dependence among repeated observations. Model assumptions were evaluated using residual diagnostics. Effect sizes were calculated using partial eta squared (η²p).
Participants were prospectively stratified according to average dizziness ratings using median split classification to create High-Dizziness and Low/No-Dizziness subgroups. Sensitivity analyses evaluated dizziness as a continuous variable to confirm robustness.
Safety Monitoring Participant safety was monitored throughout the intervention. Immediately after each session, participants completed questionnaires documenting stimulation-related sensations. No medications were administered, and no invasive procedures were performed. Participants were free to discontinue their participation at any time without providing a reason. No penalties or consequences were applied for withdrawal, and participants retained the right to withdraw their data upon request.
Scientific Significance This study was designed to extend previous laboratory investigations by evaluating autonomic and psycho-emotional responses to GVS under ecologically valid occupational conditions. By integrating acute, short-term recovery, and cumulative assessments during participants' normal professional activities, the study addresses a gap in the current literature regarding real-world applicability of vestibular neuromodulation. The prospective evaluation of subjective vestibular perception as a potential moderator of autonomic responses represents a conceptual innovation. The findings are expected to contribute to individualized non-invasive neuromodulation approaches and provide additional evidence regarding the physiological safety and tolerability of repeated sinusoidal GVS in healthy adults.
- Conditions
- Healthy Volunteers
- Being tested
- Galvanic Vestibular Stimulation (GVS) using BrainPatch device
- Keywords
- galvanic vestibular stimulation, heart rate variability, vestibulo-autonomic coupling, vestibular perception, autonomic regulation, interoception, occupational health, ecological validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galvanic Vestibular Stimulation (GVS) using BrainPatch deviceDevice
Also called GVS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Galvanic Vestibular Stimulation (GVS) using BrainPatch device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: • 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)
Comparison of HRV changes between participants stratified by dizziness intensity (High Dizziness vs Low/No Dizziness) using median split based on average dizziness ratings across intervention days. Outcomes include RR, HFnu, SD1, SD2/SD1 ratio, DFA α1, and Stress Index.
Measured: • 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
Participants rated the intensity of dizziness, warmth, burning, itching, pain, metallic taste, nausea, discomfort, and fatigue using a 4-point ordinal scale (0 = "not experienced" to 3 = "strongly experienced") immediately after each session. Average dizziness ratings across the four sessions were used to stratify participants into High Dizziness and Low/No Dizziness subgroups for secondary analyses of autonomic responses.
Measured: • Days 2-5 (immediately after each stimulation session)
Changes in Psycho-Emotional Well-Being (Depressive Symptoms, Anxiety, and Affect)
Assessment of depressive symptom severity using the Inventory of Depressive Symptomatology - Self Report (IDS-SR), anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7), and positive and negative affect using the Positive and Negative Affect Schedule (PANAS). The IDS-SR and GAD-7 were administered once at baseline (Day 1) and once at post-course assessment (Day 6). The PANAS was administered at Day 1 (upon arrival and at sensor removal) and Day 6 (upon arrival and at sensor removal).
Measured: • Baseline (Day 1) • Day 6 (post-course assessment)
Blinding Integrity Assessment
Participants were asked to indicate whether they believed they had received active GVS or sham stimulation. The distribution of guesses was compared between the Active GVS and Sham groups using Pearson's chi-square test to evaluate the effectiveness of blinding.
Measured: • Day 5 (immediately after the fourth stimulation session)
Change in Positive and Negative Affect as Measured by the PANAS
The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire consisting of two 10-item subscales measuring positive affect (PA) and negative affect (NA). Participants rate the extent to which they have experienced each emotion over the past week on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). Scores for each subscale range from 10 to 50, with higher scores indicating greater positive or negative affect. The PANAS was administered four times daily during each of the four intervention days (morning, pre-stimulation, post-stimulation, and end of workday).
Measured: • Days 2-5 (morning, pre-stimulation, post-stimulation, and end of workday)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start30 Nov 2021
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Farabi Kazakh National University
- Sponsor type
- University, hospital or other
- Collaborators
- Research and Production Center "Comprehensive Equipment", BrainPatch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715227
- Sponsor's protocol ID
- IRB A343
- Other IDs
- BR27198099, IRB-A843
- Acronym
- GVS-HRV
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article, including: Demographic and anthropometric data (age, sex, body mass index) Heart rate variability indices (time-domain: SDNN, mean RR intervals; frequency-domain: HFnu; nonlinear: SD1, SD2, SD2/SD1 ratio, DFA α1; geometric: Baevsky Stress Index) Psychometric questionnaire scores (PANAS, IDS-SR, GAD-7) Stimulation-related sensations ratings (dizziness, warmth, burning, itching) Data dictionaries defining all variables will be provided alongside the datasets.
Publications
Kollmansperger S, Decker J, Berkes S, Jahn K, Wuehr M. A mobile electrical stimulator for therapeutic modulation of the vestibular system - design, safety, and functionality. Front Neurol. 2024 Nov 13;15:1502204. doi: 10.3389/fneur.2024.1502204. eCollection 2024.
PubMed 39606706Pliego 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.
PubMed 34076918Thayer 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.
PubMed 11163422Matsugi 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.
PubMed 33679355Yamamoto 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.
PubMed 16049932Craig 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.
PubMed 19096369Shaffer 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.
PubMed 29034226Yates BJ, Bolton PS, Macefield VG. Vestibulo-sympathetic responses. Compr Physiol. 2014 Apr;4(2):851-87. doi: 10.1002/cphy.c130041.
PubMed 24715571Marchand 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.
PubMed 40289049Dlugaiczyk 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.
PubMed 30995162Heart 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.
PubMed 8737210
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Galvanic Vestibular Stimulation on Heart Rate Variability
- ClinicalTrials.gov ID
- NCT07715227
- Acronym / sponsor ID
- GVS-HRV / IRB A343
- Conditions
- Healthy Volunteers
- Keywords
- galvanic vestibular stimulation, heart rate variability, vestibulo-autonomic coupling, vestibular perception, autonomic regulation, interoception, occupational health, ecological validity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Al-Farabi Kazakh National UniversityUniversity, hospital or other
- Collaborators
- Research and Production Center "Comprehensive Equipment", BrainPatch
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Description
Scientific Background and Rationale Occupational stress is recognized as an important contributor to impaired physical and mental health. Continuous exposure to cognitive workload, emotional demands, and psychosocial stressors may alter autonomic nervous system regulation, resulting in reduced physiological adaptability and increased cardiovascular risk. Heart rate variability (HRV) is one of the most widely accepted non-invasive indicators of autonomic regulation, reflecting the dynamic interaction between sympathetic and parasympathetic branches. Reduced HRV has consistently been associated with impaired stress resilience, diminished vagal regulation, increased cardiovascular morbidity, and adverse mental health outcomes.
Galvanic vestibular stimulation (GVS) applies weak electrical currents through electrodes positioned over the mastoid processes behind the ears. The electrical current activates vestibular afferents, influencing vestibular pathways that project not only to cortical vestibular regions but also to autonomic nuclei within the brainstem. Experimental and neuroanatomical studies have demonstrated direct vestibulo-autonomic connections involving the vestibular nuclei, nucleus tractus solitarius, dorsal motor nucleus of the vagus nerve, and other cardiovascular regulatory centers. Through these pathways, vestibular stimulation may influence autonomic cardiovascular regulation and HRV.
Several laboratory studies have reported that GVS may increase parasympathetic activity, reduce sympathetic influence, and modify cardiovascular reflexes. However, reported autonomic effects vary considerably across studies due to differences in stimulation parameters, waveforms, current intensity, recording conditions, and participant characteristics. Most previous investigations were conducted under highly controlled laboratory conditions, which maximize internal validity but limit ecological validity and clinical translation.
Recent technological advances have facilitated the development of portable GVS systems suitable for ambulatory use. These developments have created opportunities to evaluate vestibular neuromodulation under real-life conditions, where autonomic regulation is continuously challenged by natural fluctuations in cognitive workload, emotional demands, posture, movement, fatigue, and environmental stressors. Despite increasing interest in wearable neuromodulation technologies, the physiological effects of repeated GVS administered during normal occupational activities remain insufficiently investigated.
An additional unresolved question concerns the considerable inter-individual variability in subjective responses to vestibular stimulation. Some individuals experience pronounced sensations of self-motion or dizziness during GVS, whereas others report minimal or no vestibular sensations despite receiving identical stimulation parameters. This variability suggests that autonomic responses may depend not only on the physical characteristics of vestibular stimulation but also on the degree of conscious vestibular perception.
Current concepts of interoception and predictive processing propose that autonomic regulation is dynamically influenced by the brain's interpretation of incoming bodily signals rather than by peripheral sensory input alone. According to these models, physiological responses may be modulated by the subjective significance of sensory information and by prediction errors generated when incoming vestibular information conflicts with visual and proprioceptive signals. Therefore, conscious perception of vestibular stimulation may represent an important determinant of autonomic adaptation.
Detailed Methodology The study was conducted in two occupational settings: rest facilities of Kazakhtelecom JSC and the neurocognitive laboratories of the Brain Institute at Farabi University.
Following enrollment and baseline assessment, participants entered a four-day intervention period with one study visit per day. Each visit followed an identical protocol. Upon arrival, participants were fitted with a Polar H10 chest-mounted heart rate sensor for continuous ambulatory ECG recording. After sensor placement, participants completed the first PANAS assessment. ECG recording continued while participants performed their routine occupational activities. Immediately before stimulation, participants completed a second PANAS assessment. They subsequently received either active or sham GVS while seated comfortably with their eyes closed, listening to standardized meditative music. Immediately following stimulation, participants completed a third PANAS assessment together with a standardized questionnaire evaluating stimulation-related sensations (dizziness, warmth, burning, itching, each rated on a 4-point scale from 0 = "not experienced" to 3 = "strongly experienced"). Approximately one hour after stimulation, the sensor was removed and participants completed the fourth PANAS assessment. On the final intervention day, participants indicated whether they believed they had received active or sham stimulation to evaluate blinding integrity.
One to two days after the intervention course, participants underwent a post-intervention assessment identical to baseline procedures, including ambulatory ECG monitoring and psychometric evaluation.
Heart Rate Variability Assessment Continuous RR interval data were acquired using the Polar H10 sensor. Recordings were exported for offline processing using Kubios HRV Premium software. Artifact correction and interpolation procedures were applied before HRV calculation. HRV indices were calculated for consecutive six-minute epochs according to international recommendations.
Time-domain indices included mean RR intervals and SDNN. Frequency-domain analysis included normalized high-frequency power (HFnu). Low-frequency power was excluded from primary analyses because the stimulation frequency (0.1 Hz) overlapped with the conventional low-frequency HRV band, potentially confounding physiological interpretation. Nonlinear indices included SD1, SD2, the SD2/SD1 ratio, and detrended fluctuation analysis (DFA α1). The Baevsky Stress Index was calculated as an integrative geometric measure of regulatory strain.
HRV was analyzed at three temporal scales: acute (six-minute epochs before, during, and after stimulation), macro-scale (one-hour pre- and post-stimulation recordings), and course-level (baseline versus post-intervention comparisons).
Psychometric Assessment Psycho-emotional functioning was evaluated using standardized self-report questionnaires. The Positive and Negative Affect Schedule (PANAS) was administered repeatedly to assess short-term affective changes. Depressive symptoms were evaluated using the Inventory of Depressive Symptomatology - Self Report (IDS-SR). Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Validated Russian-language versions were used for all questionnaires.
Statistical Analysis Baseline characteristics were compared using parametric or non-parametric tests depending on data distribution. Categorical variables were analyzed using Pearson's chi-square tests.
Psychometric outcomes were analyzed using repeated-measures ANOVA and ANCOVA with baseline adjustment when appropriate. Post hoc comparisons were corrected using Bonferroni adjustment.
Primary autonomic analyses were performed using linear mixed-effects models estimated by restricted maximum likelihood. Separate models were constructed for acute, macro-scale, and cumulative analyses. Mean heart rate was included as a time-varying covariate. Random intercepts were specified for individual participants, and first-order autoregressive covariance structures were applied to model temporal dependence among repeated observations. Model assumptions were evaluated using residual diagnostics. Effect sizes were calculated using partial eta squared (η²p).
Participants were prospectively stratified according to average dizziness ratings using median split classification to create High-Dizziness and Low/No-Dizziness subgroups. Sensitivity analyses evaluated dizziness as a continuous variable to confirm robustness.
Safety Monitoring Participant safety was monitored throughout the intervention. Immediately after each session, participants completed questionnaires documenting stimulation-related sensations. No medications were administered, and no invasive procedures were performed. Participants were free to discontinue their participation at any time without providing a reason. No penalties or consequences were applied for withdrawal, and participants retained the right to withdraw their data upon request.
Scientific Significance This study was designed to extend previous laboratory investigations by evaluating autonomic and psycho-emotional responses to GVS under ecologically valid occupational conditions. By integrating acute, short-term recovery, and cumulative assessments during participants' normal professional activities, the study addresses a gap in the current literature regarding real-world applicability of vestibular neuromodulation. The prospective evaluation of subjective vestibular perception as a potential moderator of autonomic responses represents a conceptual innovation. The findings are expected to contribute to individualized non-invasive neuromodulation approaches and provide additional evidence regarding the physiological safety and tolerability of repeated sinusoidal GVS in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active GVS | Experimental | Device: Galvanic Vestibular Stimulation (GVS) using BrainPatch deviceParticipants 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. |
| Sham GVS | Sham comparator | Device: Galvanic Vestibular Stimulation (GVS) using BrainPatch deviceAn 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet any of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galvanic Vestibular Stimulation (GVS) using BrainPatch deviceAlso: GVSSinusoidal 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. | Device | Active GVS, Sham GVS |
Primary outcome
Change in Heart Rate Variability (HRV) Indices from Baseline to Post-Course and During Acute Stimulation
Time frame: • 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)
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.
5 secondary outcomes
Autonomic Responses by Vestibular Perception Subgroups (High vs Low/No Dizziness)
Time frame: • 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
Time frame: • Days 2-5 (immediately after each stimulation session)
Changes in Psycho-Emotional Well-Being (Depressive Symptoms, Anxiety, and Affect)
Time frame: • Baseline (Day 1) • Day 6 (post-course assessment)
Blinding Integrity Assessment
Time frame: • Day 5 (immediately after the fourth stimulation session)
Change in Positive and Negative Affect as Measured by the PANAS
Time frame: • Days 2-5 (morning, pre-stimulation, post-stimulation, and end of workday)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 39606706Kollmansperger S, Decker J, Berkes S, Jahn K, Wuehr M. A mobile electrical stimulator for therapeutic modulation of the vestibular system - design, safety, and functionality. Front Neurol. 2024 Nov 13;15:1502204. doi: 10.3389/fneur.2024.1502204. eCollection 2024.
- Background: PubMed 34076918Pliego 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.
- Background: PubMed 11163422Thayer 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.
- Background: PubMed 33679355Matsugi 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.
- Background: PubMed 16049932Yamamoto 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.
- Background: PubMed 19096369Craig 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.
- Background: PubMed 29034226Shaffer 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.
- Background: PubMed 24715571Yates BJ, Bolton PS, Macefield VG. Vestibulo-sympathetic responses. Compr Physiol. 2014 Apr;4(2):851-87. doi: 10.1002/cphy.c130041.
- Background: PubMed 40289049Marchand 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.
- Background: PubMed 30995162Dlugaiczyk 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.
- Background: PubMed 8737210Heart 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article, including: Demographic and anthropometric data (age, sex, body mass index) Heart rate variability indices (time-domain: SDNN, mean RR intervals; frequency-domain: HFnu; nonlinear: SD1, SD2, SD2/SD1 ratio, DFA α1; geometric: Baevsky Stress Index) Psychometric questionnaire scores (PANAS, IDS-SR, GAD-7) Stimulation-related sensations ratings (dizziness, warmth, burning, itching) Data dictionaries defining all variables will be provided alongside the datasets.
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galvanic Vestibular Stimulation (GVS) using BrainPatch device in people with Healthy Volunteers, run by Al-Farabi Kazakh National University at 2 sites in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate Variability (HRV) Indices from Baseline to Post-Course and During Acute Stimulation (time frame: • 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07715227, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.