Transcranial Vibrating System for Improving Outcomes of Vestibular Physical Therapy

Transcranial Vibrating System for Improving Vestibular Physical Therapy

Sponsors

Lead sponsor: Otolith Labs

Source Otolith Labs
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.

Overall Status Recruiting
Start Date December 8, 2018
Completion Date June 2019
Primary Completion Date May 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in duration of the vestibular physical therapy exercise session up to 30 minutes
Change in dizziness index Questionaire immediately after the end of physical therapy exercise
Change in balance During first and last vestibular physical therapy visit; expected duration maximum 10 minutes
Enrollment 80
Condition
Intervention

Intervention type: Device

Intervention name: Transcranial vibrating system

Description: The transcranial vibrating system (TCVS) will be worn by participants performing vestibular physical therapy (PT) exercises. The TCVS vibrating element will be placed against the skull, preferably over the mastoid bone behind the ear and will be hold in place by a headband. The TCVS will be worn during the whole time of the vestibular PT exercise (30 minutes) or less if the participant is unable to complete its exercises. The TCVS will be set at an optimal vibration frequency as determined in a previous study.

Intervention type: Device

Intervention name: Transcranial vibrating system sham

Description: A transcranial vibrating system (TCVS) sham set at an irrelevant vibrating frequency will be worn by participants performing vestibular physical therapy (PT) exercises in arm 2. The TCVS sham vibrating element will be placed against the skull, preferably over the mastoid bone behind the ear and will be hold in place by a headband. The TCVS sham will be worn during the whole time of the vestibular PT exercise (30 minutes) or less if the participant is unable to complete its exercises.

Arm group label: Vs transcranial vibrating system sham

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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Didier Depireux, PhD Study Director Otolith Labs
Overall Contact

Last name: Didier Depireux, PhD

Phone: 410-925-6546

Email: [email protected]

Location
facility status contact investigator
Fyzical - Dizziness and Fall Prevention - Shady Grove | Rockville, Maryland, 20850, United States Not yet recruiting Michael Siegel, MD 240-361-9000 Michael Siegel, MD Principal Investigator
FYZICAL Therapy & Balance Center of Rockville | Rockville, Maryland, 20850, United States Recruiting Danielle Tate, DPT 240-361-9000 Danielle Tate, DPT Principal Investigator
Location Countries

United States

Verification Date

January 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Transcranial vibrating system effect

Arm group type: Experimental

Description: Participants will be enrolled for a 4 week period and will have 2 vestibular physical therapy (PT) visits per week. During the first 2 weeks (4 visits), 20 participants will perform their PT exercises (30 minutes or less if the participant is too dizzy to finish) wearing the transcranial vibration system (TCVS) and the other 20 participants without. The following 2 consecutive weeks (4 visits), participants will perform their PT exercises wearing the TCVS if they weren't previously, or won't wear the device during their PT exercises if they were previously. Outcomes measured: at every visit: dizziness at the end of PT exercise (with dizziness symptom scale DSS); duration of PT exercise at the first and last visit: force plate system assessment (balance)

Arm group label: Vs transcranial vibrating system sham

Arm group type: Sham Comparator

Description: 40 participants will be enrolled for a 4 week period and will have 2 vestibular physical therapy (PT) visits per week. Participants will perform their PT exercises (30 minutes or less if the participant is too dizzy to finish) wearing the transcranial vibration system (TCVS) at optimal vibrating frequency or wearing the TCVS at irrelevant vibrating frequency (sham). The TCVS and TCVS sham will be labeled A or B by the sponsor. The investigators and participants will not know which TCVS is optimal or sham. The sponsor will randomly assign participants TCVS A or B. Outcomes measured: at every visit: dizziness at the end of PT exercise (with dizziness symptom scale DSS); duration of PT exercise at the first and last visit: force plate system assessment (balance)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Sequential Assignment

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

Masking: Double (Participant, Investigator)

Masking description: Arm 1: their will be no masking as the participants will either wear the transcranial vibrating system (TCVS) or not.
Arm 2: the investigators will be provided 2 TCVS by the sponsor, labeled A or B, which will be randomly assigned to participants by the sponsor. One TCVS will be set at the optimal vibration frequency and the other TCVS will be set at an irrelevant vibration frequency (sham). The investigators and the participants will not know which TCVS is optimal or sham, thus the arm 2 will be double blinded.

Source: ClinicalTrials.gov