Sinusoidal Galvanic Vestibular Stimulation for Neurogenic Orthostatic Hypotension / Syncope

Summary

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.

Conditions

• Neurogenic Orthostatic Hypotension

Interventions

DEVICE

Sinosuidal Galvanic Vestibular Stimulation

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 (VLF) bipolar, ± 2 mA, 0.025 Hz oscillating current sGVS between the mastoids

DEVICE

Placebo

When assigned to placebo arm of the study, the patients will undergo same procedure as the treatment, only current will not be passed. (the device will still be placed on the mastoid process)

Sponsors & Collaborators

• Hackensack Meridian Health

  lead OTHER

Principal Investigators

• Martin Gizzi, MD · HUMC NSI

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2025-02-15

Completion

2025-02-15

Countries

• United States

Study Locations