Transcranial Vibrating System for Improving Vestibular Physical Therapy

Otolith Labs

Status: Terminated

Conditions: Balance; Nausea; Vertigo; Dizziness

Treatments: Device: Transcranial vibrating system; Device: Transcranial vibrating system sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT03795168

OLith10301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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1 participants in 2 patient groups

Transcranial vibrating system effect

Experimental group

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)

Treatment:

Device: Transcranial vibrating system

Vs transcranial vibrating system sham

Sham Comparator group

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)

Treatment:

Device: Transcranial vibrating system

Device: Transcranial vibrating system sham