Nausea Clinical Trial
Official title:
Transcranial Vibrating System for Improving Outcomes of Vestibular Physical Therapy
Verified date | March 2022 |
Source | Otolith Labs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Otolith Labs |
United States,
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 |
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