Vibration Impact on Parkinson's Tremor

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: RMBand lower dose; Device: RMBand higher dose

• Registration Number: NCT03799614
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-10
• Study Start: 2019-02-26
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Status Verified: 2020-11
• Results First Submitted: 2020-11-19
• Results First Submitted QC: 2020-11-19
• Last Update Submitted: 2020-11-19
• Results First Posted: 2020-12-17
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower dose vibration	RMBand lower dose	RMBand lower dose vibration
Higher dose vibration	RMBand higher dose	RMBand higher dose vibration

Primary Outcome Measures

Name	Time	Method
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)	This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.	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.
Clinical Rating for Tremor	Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. .	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.
Objective Measurement of Tremor Frequency (Hz)	Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.	This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment.
Objective Measurement of Tremor Amplitude (mm).	Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.	This is a device that will objectively measure tremor amplitude pre, during, and post treatment.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States