Transcranial Vibrating System for Improving Vestibular Physical Therapy
Vertigo, Dizziness, Nausea
About this trial
This is an interventional treatment trial for Vertigo focused on measuring Vestibular physical therapy, Positional vertigo, Ménière's disease
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.
Sites / Locations
- Fyzical - Dizziness and Fall Prevention - Shady Grove
- FYZICAL Therapy & Balance Center of Rockville
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Transcranial vibrating system effect
Vs transcranial vibrating system sham
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)