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Behavioural Intervention

Sinosuidal Galvanic Vestibular Stimulation for Neurogenic Orthostatic Hypotension

N/A
Waitlist Available
Led By Martin Gizzi, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient with unexpected intermittent syncope or a positive tilt test
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week prior vs 1 week after treatment
Awards & highlights

Study Summary

This trial is testing whether a treatment using electrical stimulation can help people with neurogenic orthostatic hypotension, a condition which causes fainting and has no current effective treatment.

Eligible Conditions
  • Neurogenic Orthostatic Hypotension

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week prior vs 1 week after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week prior vs 1 week after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Net change in blood pressure during head-up tilt
Net change in heart rate during head-up tilt
Secondary outcome measures
Change in frequency of low frequency oscillations in blood pressure and heart rate during tilt testing
Change in frequency of syncope in the week prior vs week after treatment
Gain of baroreceptor sensitivity
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sinusoidal Galvanic Vestibular StimulationExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,244 Total Patients Enrolled
Martin Gizzi, MDPrincipal InvestigatorHUMC NSI

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what type of individuals is enrollment in this research project appropriate?

"This clinical trial is recruiting 15 candidates that suffer from hypotension and orthostatic issues, who are within the ages of 18 to 85."

Answered by AI

What results are the investigators hoping to obtain from this trial?

"The primary measure of efficacy within this medical trial, assessed over a week-long pre and post intervention period, is the net change in heart rate while undertaking head-up tilt. Secondary objectives encompass changes to syncope frequency during the same timeframe, baroreceptor sensitivity gain, as well as alterations to low frequency oscillations observed when measuring blood pressure and heart rate during tilt testing."

Answered by AI

Is this clinical experiment currently enrolling participants?

"As per information on clinicaltrials.gov, this particular medical trial is not currently seeking new participants. It was first posted in January 1st 2023 and the last update occured on May 6th 2022. Despite this study's inactive status at present, there are still 110 other trials that actively accept patients for enrollment."

Answered by AI

Is enrollment available to individuals past the age of 35 for this research endeavor?

"According to the parameters of this medical trial, enrollees must be between 18 and 85 years old."

Answered by AI
~0 spots leftby Feb 2025