Vestibular Research Studies
Below are clinical studies that are currently recruiting research study participants. You can find more studies recruiting patients at ClinicalTrials.gov.
*If you are a VeDA professional member and would like to recruit participants for your research study, click here to submit your request.
Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere’s
Objective: Efficacy of venlafaxine in decreasing the number and severity of vertigo episodes and improving functional and QOL outcomes
Participant Information: We intend to recruit 40 patients with definite Meniere’s disease in one or both ears, who have two or more vertigo spells in the month prior to enrollment and at least a moderate disability score on the dizziness handicap inventory (DHI). Patients with the following will be excluded: other concurrent vestibular or balance disorder (especially those with vestibular migraine-related vertigo episodes despite not meeting diagnostic criteria for vestibular migraine); prior treatment with venlafaxine; history of medical (e.g., gentamicin) or surgical (e.g., labyrinthectomy) vestibular ablative treatment; history of otologic, lateral skull base, or brain surgery; history of radiation to the head or neck; known neurologic disorder affecting cognition; currently taking another serotonin modulating medication; seizures; stroke; myocardial infarction; hepatic or renal impairment; hyperlipidemia; coagulopathy; psychiatric disorder other than anxiety or depression; glaucoma; uncontrolled hypertension; and pregnancy or intention of pregnancy. Migraine itself is not an exclusion criteria.
This is a randomized, double-blind, crossover trial which will require a treatment group and a placebo group. After a screening period of one month during which they will keep a diary of each vertigo episode and follow a low salt diet and stop any potential interacting drugs as well as diuretics or betahistine (if they are not working). Patients on diuretics for high blood pressure can remain on them.
Subjects who have more than two episodes in that screening period will be offered enrollment and randomly assigned to two groups, one taking daily venlafaxineER 37.5 mg capsule and the other taking a daily placebo replica of venlafaxine manufactured by our university investigational drug services pharmacy. After two months, the subjects will wean off the drug or the placebo over a 2-week period. After a 4 week period called washout period, the study subjects will not be taking any medication. Following that, all subjects who were taking the venlafaxine will be switched by the investigative pharmacy to the placebo group and all the subjects taking the placebo will be placed on the venlafaxine for another two months. Total duration of the study from enrollment to conclusion is 5.5 months.
Subjects will be eligible to continue standard of care treatment at the conclusion of the study.
Study Status: Recruiting
Sponsor: American Hearing Research Foundation
Collaborators: Medical University of South Carolina
Contact Info: Principal Investigator Habib Rizk MD. MSc
[email protected] or on 215.459.0435
Location: Charleston, South Carolina on the campus of the Medical University of South Carolina (Rutledge Tower building)
NCT Number: NCT04218123
Vestibular Rehabilitation Utilizing Virtual Environments to Train Sensory Integration for Postural Control
Objective: Compare balance training in a novel virtual reality app to ‘standard’ vestibular balance training.
Participant Information: Eligibility: Adult patients (18 or older) with a clinical diagnosis of chronic (3 months and longer) unilateral peripheral vestibular hypofunction.
Number of participants: 28
Schedule: 2 assessment sessions, 8 intervention sessions (once per week), 1 post assessment session.
Procedure: balance assessment of 60-90 minutes; intervention will include vestibular rehabilitation with or without immersive virtual reality training (depending on randomization); repeat balance assessment.
Information gathered: demographics, medical history, self-reported questionnaires, functional balance tests, postural sway measures from force plate and head movement from virtual reality headset.
Reimbursement: participants will receive a $20 gift card for each assessment (for a total of $60).
Study Status: Recruiting
Sponsor: New York University Physical Therapy & New York Eye and Ear Infirmary of Mount Sinai
Collaborators: NIH REACT
Contact Info: Jennifer Kelly
Location: 380 2nd Ave, New York, NY
E-Mail: [email protected]
NCT Number: NCT04268745