Vibration Impact on Parkinson's Tremor

NCT03799614 | Completed Results FDA Device

• 1 other identifier: HM20012404
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

Lower dose vibration

EXPERIMENTAL

RMBand lower dose vibration

Device: RMBand lower dose

Higher dose vibration

EXPERIMENTAL

RMBand higher dose vibration

Device: RMBand higher dose

Interventions

RMBand lower dose DEVICE

Light-weight portable device that delivers low dose vibration to the arm

Lower dose vibration

RMBand higher dose DEVICE

Light-weight portable device that delivers higher dose vibration to the arm

Higher dose vibration

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's disease (PD) as diagnosed by a movement disorder specialist
• Tremor caused by their Parkinson's disease
• Ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Ingrid Pretzer-Aboff
• Organization: Virginia Commonwealth University

iaboff@vcu.edu

804-828-3340

Study Officials

• Ingrid Pretzer-Aboff, PhD, RN

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 10, 2019
• Study Start: February 26, 2019
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)