Vibration Impact on Parkinson's Tremor

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: RMBand lower dose; Device: RMBand higher dose

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 93 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Ingrid Pretzer-Aboff, PhD, RN, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Actual): November 27, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: HM20012404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes