N/A
Completed N=30
Vibration Impact on Parkinson's Tremor
Source: ClinicalTrials.gov NCT03799614 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) — 32.67; 27.4; 33.67; 27.33 score on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) |
32.67; 27.4; 33.67; 27.33; 32.67; 28.6 | — |
| PRIMARY Clinical Rating for Tremor |
15.47; 13.87; 15.87; 13.20; 14.53; 14.13 | — |
| PRIMARY Objective Measurement of Tremor Frequency (Hz) |
4.77; 4.51; 4.79; 3.99; 3.36; 4.64 | — |
| PRIMARY Objective Measurement of Tremor Amplitude (mm). |
0.71; 0.43; 0.76; 0.44; 0.70; 0.52 | — |
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
Data sourced from ClinicalTrials.gov (NCT03799614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.