Sinusoidal Galvanic Vestibular Stimulation for Neurogenic Orthostatic Hypotension / Syncope

NCT04976101 | Withdrawn

• 1 other identifier: Pro2020-0755
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Net change in blood pressure during head-up tilt

  Blood pressure is measured during a head up tilt test and recorded

  1 week prior vs 1 week after treatment

• Net change in heart rate during head-up tilt

  Heart rate is measured during a head up tilt test and recorded

  1 week prior vs 1 week after treatment

Secondary Outcomes (4)

• Gain of baroreceptor sensitivity

  1 week prior vs 1 week after treatment

• Phase of baroreceptor sensitivity

  1 week prior vs 1 week after treatment

• Change in frequency of syncope in the week prior vs week after treatment

  1 week prior vs 1 week after treatment

• Change in frequency of low frequency oscillations in blood pressure and heart rate during tilt testing

  1 week prior vs 1 week after treatment

Study Arms (2)

Sinusoidal Galvanic Vestibular Stimulation

EXPERIMENTAL

Treatment: 1\. Stimulation of the vestibular nerves with 0.025 Hz, 2 mA sinusoidal galvanic vestibular stimulation Depending on initial results, changes in frequency may range up to 0.1 Hz.

Device: Sinosuidal Galvanic Vestibular Stimulation

Placebo

PLACEBO COMPARATOR

Treatment: 1\. Placebo (sham) (no current given however the electrodes and devise is placed and computer keys pressed). Depending on initial results, changes in frequency may range up to 0.1 Hz.

Device: Placebo

Interventions

Sinosuidal Galvanic Vestibular Stimulation DEVICE

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

Sinusoidal Galvanic Vestibular Stimulation

Placebo DEVICE

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)

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with unexpected intermittent syncope or a positive tilt test

You may not qualify if:

• Syncope cannot be related to significant heart disease
• cannot be not be related to serious medical illnesses that cause increased susceptibility to fainting, such as in Parkinson's Disease
• Pregnant or lactating women

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Univeristy Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (43)

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Study Officials

• Martin Gizzi, MD

  HUMC NSI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 26, 2021
• Study Start: January 1, 2023
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)