Transcranial Vibrating System for Improving Vestibular Physical Therapy

Nausea Clinical Trial

Official title:

Transcranial Vibrating System for Improving Outcomes of Vestibular Physical Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03795168
• Other study ID #: OLith10301
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 1, 2019

Study information

• Verified date: March 2022
• Source: Otolith Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Balance
• Dizziness
• Nausea
• Vertigo

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Fyzical - Dizziness and Fall Prevention - Shady Grove	Rockville	Maryland
United States	FYZICAL Therapy & Balance Center of Rockville	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Otolith Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 30 minutes
Primary	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	Questionaire immediately after the end of physical therapy exercise
Primary	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.	During first and last vestibular physical therapy visit; expected duration maximum 10 minutes