Vibration Impact on Parkinson's Tremor

Study Overview
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Brief Summary
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The primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject's arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson's disease (PD).

Detailed Description
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Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling.

Official Title
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Vibration Impact on Parkinson's Tremor

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: RMBand lower dose
* Device: RMBand higher dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's disease (PD) as diagnosed by a movement disorder specialist Tremor caused by their Parkinson's disease Ability to provide informed consent Exclusion Criteria: Known diagnosis of Parkinson Plus Syndrome Dementia Other known non-PD cause of tremor Other known non-PD cause of limb dysfunction Presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus Non-English speaker Prisoners Pregnant women

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower dose vibration<br>RMBand lower dose vibration | Device: RMBand lower dose<br>* Light-weight portable device that delivers low dose vibration to the arm<br>|
| Experimental: Higher dose vibration<br>RMBand higher dose vibration | Device: RMBand higher dose<br>* Light-weight portable device that delivers higher dose vibration to the arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | The Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 - 136. It takes   5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off. | 
| Clinical Rating for Tremor | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 - 14 will be used to report average changes in tremor. Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 - 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. | Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. . | 
| Objective Measurement of Tremor Frequency (Hz) | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. | 
| Objective Measurement of Tremor Amplitude (mm). | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. |