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Vibration Impact on Parkinson's Tremor

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RMBand lower dose
RMBand higher dose
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lower dose vibration

Higher dose vibration

Arm Description

RMBand lower dose vibration

RMBand higher dose vibration

Outcomes

Primary Outcome Measures

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.
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.
Objective Measurement of Tremor Frequency (Hz)
This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment.
Objective Measurement of Tremor Amplitude (mm).
This is a device that will objectively measure tremor amplitude pre, during, and post treatment.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2018
Last Updated
November 19, 2020
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03799614
Brief Title
Vibration Impact on Parkinson's Tremor
Official Title
Vibration Impact on Parkinson's Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower dose vibration
Arm Type
Experimental
Arm Description
RMBand lower dose vibration
Arm Title
Higher dose vibration
Arm Type
Experimental
Arm Description
RMBand higher dose vibration
Intervention Type
Device
Intervention Name(s)
RMBand lower dose
Intervention Description
Light-weight portable device that delivers low dose vibration to the arm
Intervention Type
Device
Intervention Name(s)
RMBand higher dose
Intervention Description
Light-weight portable device that delivers higher dose vibration to the arm
Primary Outcome Measure Information:
Title
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
Description
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.
Time Frame
This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.
Title
Clinical Rating for Tremor
Description
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.
Time Frame
Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. .
Title
Objective Measurement of Tremor Frequency (Hz)
Description
This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment.
Time Frame
Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
Title
Objective Measurement of Tremor Amplitude (mm).
Description
This is a device that will objectively measure tremor amplitude pre, during, and post treatment.
Time Frame
Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid Pretzer-Aboff, PhD, RN
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Vibration Impact on Parkinson's Tremor

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