Vibration Impact on Parkinson's Tremor

Parkinson Disease Clinical Trial

Official title:

Vibration Impact on Parkinson's Tremor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799614
• Other study ID #: HM20012404
• Status: Completed
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: November 27, 2019

Study information

• Verified date: November 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• RMBand lower dose
Light-weight portable device that delivers low dose vibration to the arm
• RMBand higher dose
Light-weight portable device that delivers higher dose vibration to the arm

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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. .
Primary	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.
Primary	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.