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Transcranial Vibrating System for Improving Vestibular Physical Therapy

Primary Purpose

Vertigo, Dizziness, Nausea

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial vibrating system

Transcranial vibrating system sham

About this trial

This is an interventional treatment trial for Vertigo focused on measuring Vestibular physical therapy, Positional vertigo, Ménière's disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fyzical - Dizziness and Fall Prevention - Shady Grove
FYZICAL Therapy & Balance Center of Rockville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial vibrating system effect

Vs transcranial vibrating system sham

Arm 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)

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)

Outcomes

Primary Outcome Measures

Change in duration of the vestibular physical therapy exercise session

The participants will perform vestibular physical therapy exercises for 30 minutes unless their dizziness symptoms prevend them to finish. The change in vestibular physical therapy exercises they can perform will be recorded by the investigator. This value will be recorded immediately after they finish their physical therapy exercises.

Change in dizziness index

The dizziness index will be evaluated with the Dizziness Symptom Scale (DSS) with a scale from 1 (no dizziness) to 10 (strong dizziness). The change of DSS will be evaluated between participants wearing: the transcranial vibrating system (TCVS) no TCVS the TCVS sham

Change in balance

Participant's balance will be evaluated with a force plate platform (Bertec Device). Participants will be placed on the plate 1. eyes open, 2. eyes closed, 3. eyes open while standing on a foam pad, 4. eyes closed while standing on a foam pad. Each of the 4 conditions will involve the participant standing barefoot on a force plate platform for 10 seconds. The change in participant's balance (X&Y direction) will be assessed by recording values of the Bertec device in two conditions: first with participants not wearing the TCVS and second with participants wearing the TCVS at optimal vibration frequency or wearing the TCVS sham. Clinical parameters obtained from the Bertec system will be recorded, including "falls" and will be compared between conditions to evaluate participant's change in balance. Participants will always be held safe with a harness secured to a mount point in the ceiling.

Secondary Outcome Measures

Full Information

NCT ID

NCT03795168

First Posted

January 1, 2019

Last Updated

March 21, 2022

Sponsor

Otolith Labs

1. Study Identification

Unique Protocol Identification Number

NCT03795168

Brief Title

Transcranial Vibrating System for Improving Vestibular Physical Therapy

Official Title

Transcranial Vibrating System for Improving Outcomes of Vestibular Physical Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Study center closed down

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

March 1, 2019 (Actual)

Study Completion Date

April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otolith Labs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vertigo, Dizziness, Nausea, Balance

Keywords

Vestibular physical therapy, Positional vertigo, Ménière's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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

Masking

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transcranial vibrating system effect

Arm Type

Experimental

Arm Description

Arm Title

Vs transcranial vibrating system sham

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcranial vibrating system

Intervention 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(s)

Transcranial vibrating system sham

Intervention 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.

Primary Outcome Measure Information:

Title

Change in duration of the vestibular physical therapy exercise session

Description

Time Frame

up to 30 minutes

Title

Change in dizziness index

Description

Time Frame

Questionaire immediately after the end of physical therapy exercise

Title

Change in balance

Description

Time Frame

During first and last vestibular physical therapy visit; expected duration maximum 10 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Didier Depireux, PhD

Organizational Affiliation

Otolith Labs

Official's Role

Study Director

Facility Information:

Facility Name

Fyzical - Dizziness and Fall Prevention - Shady Grove

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

FYZICAL Therapy & Balance Center of Rockville

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Transcranial Vibrating System for Improving Vestibular Physical Therapy

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