Clinical trial NCT03795168: Transcranial Vibrating System for Improving Vestibular Physical Therapy
Official title: Transcranial Vibrating System for Improving Outcomes of Vestibular Physical Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vertigo
Dizziness
Nausea
Balance
Keywords: Vestibular physical therapy
Positional vertigo
Ménière's disease
Lead sponsor: Otolith Labs
Sponsor class: INDUSTRY
First posted: 2019-01-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Arm 1: Participants undergoing vestibular physical therapy (PT) will perform PT exercises with or without wearing the transcranial vibrating system (TCVS). Following the end of their PT exercises (30 minutes or less if the participant was too dizzy to finish), participants will evaluate dizziness using a dizziness symptom scale (DSS) and PT exercise duration will be recorded. A force plate system assessment will also be performed with or without wearing the TCVS during the first and last PT visit to evaluate participant's balance.

Arm 2: Participants will undergo the identical protocol as arm 1 with the exception that participants will wear the TCVS at optimal vibration frequency or the TCVS at irrelevant vibration frequency (sham).

To determine TCVD's effect on dizziness and balance, the outcomes measured in both arms (1. DSS, 2. duration of PT exercise, 3. balance) will be compared statistically between:

* TCVD versus no device
* TCVD optimal frequency versus TCVD sham
Primary purpose: TREATMENT

Brief summary: This research study aims to determine whether low-frequency transcranial vibrations can act as a possible treatment for the dizziness and nausea often associated with vestibular physical therapy.

Detailed description: The purpose of this study is to determine the effectiveness of a Transcranial Vibration System (TCVS) at reducing the increased nausea and discomfort sometimes associated with vestibular physical therapy. The TCVS is a small device attached to an elastic band. It is worn around the head and produces vibrations. There is no implant or surgical procedure. The FDA has made a pre-determination that this is a low-risk device (a "Class 2 device" in FDA terminology).

The TCVS has previously been tested in healthy volunteers and has been found to safely and effectively decrease dizziness and nausea associated with vestibular discomfort. This study will expand that research to vestibular disorder patients who are undergoing physical therapy. The study compares the outcomes to not wearing a device, or to a control (inneffective) device.

Eligibility criteria: Inclusion Criteria:

* reluctant or unable to perform a full session of vestibular physical therapy

Exclusion Criteria:

* History of head injury within the last six months or currently suffering the effects of a head injury (i.e. concussion or traumatic brain injury)
* Presence of severe aphasia.
* History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia).
* Documented neurodegenerative disorders.
* Pregnancy Female candidates will be asked to take a pregnancy test first and will have to make a informed decision to participate based on the results of the pregnancy test.
* History of Cerebrovascular disorders.
* History of ear operation other than myringotomy and tube placement in the past.
* Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis.

Primary outcomes:
measure: Change in duration of the vestibular physical therapy exercise session
timeFrame: up to 30 minutes
measure: Change in dizziness index
timeFrame: Questionaire immediately after the end of physical therapy exercise
measure: Change in balance
timeFrame: During first and last vestibular physical therapy visit; expected duration maximum 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Fyzical - Dizziness and Fall Prevention - Shady Grove
state: Maryland
city: Rockville
country: United States
facility: FYZICAL Therapy & Balance Center of Rockville
state: Maryland
Study officials:
affiliation: Otolith Labs
name: Didier Depireux, PhD
role: STUDY_DIRECTOR
References: