Transcranial Vibrating System for Improving Vestibular Physical Therapy

Transcranial Vibrating System for Improving Outcomes of Vestibular Physical Therapy

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.

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.

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.