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Transcranial Vibrating System for Improving Vestibular Physical Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03795168
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vertigo Dizziness Nausea Balance Device: Transcranial vibrating system Device: Transcranial vibrating system sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
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.

Primary Purpose: Treatment
Official Title: Transcranial Vibrating System for Improving Outcomes of Vestibular Physical Therapy
Actual Study Start Date : December 8, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcranial vibrating system effect

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)
Device: Transcranial vibrating system
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.

Sham Comparator: Vs transcranial vibrating system sham

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)
Device: Transcranial vibrating system
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.

Device: Transcranial vibrating system sham
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 Measures :
  1. Change in duration of the vestibular physical therapy exercise session [ Time Frame: up to 30 minutes ]
    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.

  2. Change in dizziness index [ Time Frame: Questionaire immediately after the end of physical therapy exercise ]

    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

  3. Change in balance [ Time Frame: During first and last vestibular physical therapy visit; expected duration maximum 10 minutes ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795168


Contacts
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Contact: Didier Depireux, PhD 410-925-6546 didier+fyzical@otolithlabs.com

Locations
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United States, Maryland
Fyzical - Dizziness and Fall Prevention - Shady Grove Not yet recruiting
Rockville, Maryland, United States, 20850
Contact: Michael Siegel, MD    240-361-9000      
Principal Investigator: Michael Siegel, MD         
FYZICAL Therapy & Balance Center of Rockville Recruiting
Rockville, Maryland, United States, 20850
Contact: Danielle Tate, DPT    240-361-9000      
Principal Investigator: Danielle Tate, DPT         
Sponsors and Collaborators
Otolith Labs
Investigators
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Study Director: Didier Depireux, PhD Otolith Labs

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Responsible Party: Otolith Labs
ClinicalTrials.gov Identifier: NCT03795168    
Other Study ID Numbers: OLith10301
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Otolith Labs:
Vestibular physical therapy
Positional vertigo
Ménière's disease
Additional relevant MeSH terms:
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Vertigo
Dizziness
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Sensation Disorders