Sinusoidal Galvanic Vestibular Stimulation for Neurogenic Orthostatic Hypotension / Syncope
Public ClinicalTrials.gov record NCT04976101. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Pilot Study to Assess Sinusoidal Galvanic Vestibular Stimulation in Neurogenic Orthostatic Hypotension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Neurogenic orthostatic hypotension occurs in a significant number of people and has no effective treatment. Neurogenic orthostatic hypotension is associated with intermittent episodes of fainting which can be debilitating for the patients. Using sinusoidal galvanic vestibular stimulation, an oscillating current between the two ears, collaborators have discovered an effective technique to habituate anesthetized rats that develop vasovagal responses. The investigators propose to determine whether a similar use of sinusoidal galvanic vestibular stimulation can eliminate or alleviate neurogenic orthostatic hypotension and the associated syncope in susceptible human subjects. If so, then sinusoidal galvanic vestibular stimulation, which is safe and widely used to study muscle sympathetic nerve activity, can be used in humans, who have a history of syncope and a positive tilt test to habituate vasovagal responses. Habituation will be accomplished using repetitive periods of sinusoidal galvanic vestibular stimulation in two 30min sessions three times/week for 2 weeks. Similar 1 hour sessions are routinely used by others when activating muscle sympathetic nerve activity with sinusoidal galvanic vestibular stimulation without harm to the subjects. The 30 min periods were chosen because this was effective in producing habituation of vasovagal responses. The habituating stimulus will be given by applying paste electrodes over the mastoid processes and plugging the leads into a battery driven-stimulus box, which when activated by a switch, will provide a very low frequency bipolar, ± 2 mA, 0.025 Hz oscillating current sinusoidal galvanic vestibular stimulation between the mastoids. Subjects will be seated during the stimulation. The onset and end of the stimulation period will be denoted by tones, and the subjects will be free to watch television, read, or listen to music while they are being stimulated. The effectiveness of the habituation will be determined in several ways: 1) Subjects will keep a history of the number of episodes of syncope in the inter-test intervals. 2) They will have tilt tests at the beginning and end of habituation. 3) Their blood pressure and heart rate will be recorded and the investigators will determine if there is a loss of low frequency (0.025 Hz) oscillations, which the investigators have found in animal models to disappear when the animals are habituated. 4) Habituation should be accompanied by an increase in heart rate to counteract the fall in blood pressure.
Study identification
- NCT ID
- NCT04976101
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2022
- Primary completion
- Feb 14, 2025
- Completion
- Feb 14, 2025
- Last update posted
- Dec 15, 2022
2023 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hackensack Univeristy Medical Center | Hackensack | New Jersey | 07601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04976101, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 15, 2022 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04976101 live on ClinicalTrials.gov.