Vibration Impact on Parkinson's Tremor

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: RMBand lower dose; Device: RMBand higher dose

Study type: Interventional

Funder types: Other

Identifiers

NCT03799614

HM20012404

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Lower dose vibration

Experimental group

Description:

RMBand lower dose vibration

Treatment:

Device: RMBand lower dose

Higher dose vibration

Experimental group

Description:

RMBand higher dose vibration

Treatment:

Device: RMBand higher dose