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Completed

NCT Number: NCT03799614

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).

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Key information

Conditions

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

Age range

21 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RMBand lower dose

Device

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

RMBand higher dose

Device

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

Primary outcomes

  1. Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)

    Time frame: 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.

  2. Clinical Rating for Tremor

    Time frame: 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.

  3. Objective Measurement of Tremor Frequency (Hz)

    Time frame: 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.

  4. Objective Measurement of Tremor Amplitude (mm).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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