Parkinson Disease
Conditions
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.
Interventions
DEVICERMBand lower dose
Light-weight portable device that delivers low dose vibration to the arm
DEVICERMBand higher dose
Light-weight portable device that delivers higher dose vibration to the arm
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | 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. |
| Clinical Rating for Tremor | 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. |
| Objective Measurement of Tremor Frequency (Hz) | 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. |
| Objective Measurement of Tremor Amplitude (mm). | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lower Dose Vibration RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm | 15 |
| Higher Dose Vibration RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Lower Dose Vibration | Higher Dose Vibration | Total |
|---|---|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 6.7 | 67.6 years STANDARD_DEVIATION 8.4 | 67.4 years STANDARD_DEVIATION 7.63 |
| Clinical Rating Scale for Tremor, total score | 21.13 units on a scale STANDARD_DEVIATION 10.69 | 18.07 units on a scale STANDARD_DEVIATION 5.22 | 19.6 units on a scale STANDARD_DEVIATION 8.55 |
| MDS UPDRS II - IV total | 44.26 units on a scale STANDARD_DEVIATION 16.41 | 38.47 units on a scale STANDARD_DEVIATION 14.08 | 41.37 units on a scale STANDARD_DEVIATION 15.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 14 Participants | 29 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 1 / 15 |
| other Total, other adverse events | 0 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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.
Time frame: Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Dose Vibration | Clinical Rating for Tremor | Baseline | 15.47 score on a scale | Standard Deviation 7.94 |
| Low Dose Vibration | Clinical Rating for Tremor | During vibration | 15.87 score on a scale | Standard Deviation 8.55 |
| Low Dose Vibration | Clinical Rating for Tremor | Post vibration | 14.53 score on a scale | Standard Deviation 7.98 |
| Higher Dose Vibration | Clinical Rating for Tremor | Baseline | 13.87 score on a scale | Standard Deviation 4.03 |
| Higher Dose Vibration | Clinical Rating for Tremor | During vibration | 13.20 score on a scale | Standard Deviation 4.03 |
| Higher Dose Vibration | Clinical Rating for Tremor | Post vibration | 14.13 score on a scale | Standard Deviation 5.63 |
Primary
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.
Time frame: This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Dose Vibration | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Baseline | 32.67 score on a scale | Standard Deviation 12.88 |
| Low Dose Vibration | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | During vibration treatment | 33.67 score on a scale | Standard Deviation 14.31 |
| Low Dose Vibration | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Post vibration treatment | 32.67 score on a scale | Standard Deviation 13.67 |
| Higher Dose Vibration | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Baseline | 27.4 score on a scale | Standard Deviation 11.25 |
| Higher Dose Vibration | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | During vibration treatment | 27.33 score on a scale | Standard Deviation 11.14 |
| Higher Dose Vibration | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Post vibration treatment | 28.6 score on a scale | Standard Deviation 10.39 |
Primary
Objective Measurement of Tremor Amplitude (mm).
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Dose Vibration | Objective Measurement of Tremor Amplitude (mm). | Baseline | 0.71 millimeters | Standard Deviation 0.82 |
| Low Dose Vibration | Objective Measurement of Tremor Amplitude (mm). | During vibration | 0.76 millimeters | Standard Deviation 0.72 |
| Low Dose Vibration | Objective Measurement of Tremor Amplitude (mm). | Post vibration | 0.70 millimeters | Standard Deviation 0.75 |
| Higher Dose Vibration | Objective Measurement of Tremor Amplitude (mm). | Baseline | 0.43 millimeters | Standard Deviation 0.41 |
| Higher Dose Vibration | Objective Measurement of Tremor Amplitude (mm). | During vibration | 0.44 millimeters | Standard Deviation 0.31 |
| Higher Dose Vibration | Objective Measurement of Tremor Amplitude (mm). | Post vibration | 0.52 millimeters | Standard Deviation 0.47 |
Primary
Objective Measurement of Tremor Frequency (Hz)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Dose Vibration | Objective Measurement of Tremor Frequency (Hz) | Baseline | 4.77 hertz | Standard Deviation 1.57 |
| Low Dose Vibration | Objective Measurement of Tremor Frequency (Hz) | During Vibration | 4.79 hertz | Standard Deviation 1.13 |
| Low Dose Vibration | Objective Measurement of Tremor Frequency (Hz) | Post Vibration | 3.36 hertz | Standard Deviation 0.87 |
| Higher Dose Vibration | Objective Measurement of Tremor Frequency (Hz) | During Vibration | 3.99 hertz | Standard Deviation 1.12 |
| Higher Dose Vibration | Objective Measurement of Tremor Frequency (Hz) | Baseline | 4.51 hertz | Standard Deviation 1.31 |
| Higher Dose Vibration | Objective Measurement of Tremor Frequency (Hz) | Post Vibration | 4.64 hertz | Standard Deviation 1.48 |