Trial Outcomes & Findings for Vibration Impact on Parkinson's Tremor (NCT NCT03799614)
NCT ID: NCT03799614
Last Updated: 2020-12-17
Results Overview
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.
COMPLETED
NA
30 participants
This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.
2020-12-17
Participant Flow
Participant milestones
| Measure |
Low Dose Vibration
RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm
|
High Dose Vibration
RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vibration Impact on Parkinson's Tremor
Baseline characteristics by cohort
| Measure |
Lower Dose Vibration
n=15 Participants
RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm
|
Higher Dose Vibration
n=15 Participants
RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
67.6 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
67.4 years
STANDARD_DEVIATION 7.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Clinical Rating Scale for Tremor, total score
|
21.13 units on a scale
STANDARD_DEVIATION 10.69 • n=5 Participants
|
18.07 units on a scale
STANDARD_DEVIATION 5.22 • n=7 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 8.55 • n=5 Participants
|
|
MDS UPDRS II - IV total
|
44.26 units on a scale
STANDARD_DEVIATION 16.41 • n=5 Participants
|
38.47 units on a scale
STANDARD_DEVIATION 14.08 • n=7 Participants
|
41.37 units on a scale
STANDARD_DEVIATION 15.56 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Low Dose Vibration
n=15 Participants
RMBand low dose vibration
RMBand: Light-weight portable device that delivers low dose vibration to the arm
|
Higher Dose Vibration
n=15 Participants
RMBand high dose vibration
RMBand: Light-weight portable device that delivers higher dose vibration to the arm
|
|---|---|---|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
During vibration treatment
|
33.67 score on a scale
Standard Deviation 14.31
|
27.33 score on a scale
Standard Deviation 11.14
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
Post vibration treatment
|
32.67 score on a scale
Standard Deviation 13.67
|
28.6 score on a scale
Standard Deviation 10.39
|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
Baseline
|
32.67 score on a scale
Standard Deviation 12.88
|
27.4 score on a scale
Standard Deviation 11.25
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Low Dose Vibration
n=15 Participants
RMBand low dose vibration
RMBand: Light-weight portable device that delivers low dose vibration to the arm
|
Higher Dose Vibration
n=15 Participants
RMBand high dose vibration
RMBand: Light-weight portable device that delivers higher dose vibration to the arm
|
|---|---|---|
|
Clinical Rating for Tremor
Baseline
|
15.47 score on a scale
Standard Deviation 7.94
|
13.87 score on a scale
Standard Deviation 4.03
|
|
Clinical Rating for Tremor
During vibration
|
15.87 score on a scale
Standard Deviation 8.55
|
13.20 score on a scale
Standard Deviation 4.03
|
|
Clinical Rating for Tremor
Post vibration
|
14.53 score on a scale
Standard Deviation 7.98
|
14.13 score on a scale
Standard Deviation 5.63
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Low Dose Vibration
n=15 Participants
RMBand low dose vibration
RMBand: Light-weight portable device that delivers low dose vibration to the arm
|
Higher Dose Vibration
n=15 Participants
RMBand high dose vibration
RMBand: Light-weight portable device that delivers higher dose vibration to the arm
|
|---|---|---|
|
Objective Measurement of Tremor Frequency (Hz)
Baseline
|
4.77 hertz
Standard Deviation 1.57
|
4.51 hertz
Standard Deviation 1.31
|
|
Objective Measurement of Tremor Frequency (Hz)
During Vibration
|
4.79 hertz
Standard Deviation 1.13
|
3.99 hertz
Standard Deviation 1.12
|
|
Objective Measurement of Tremor Frequency (Hz)
Post Vibration
|
3.36 hertz
Standard Deviation 0.87
|
4.64 hertz
Standard Deviation 1.48
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Low Dose Vibration
n=15 Participants
RMBand low dose vibration
RMBand: Light-weight portable device that delivers low dose vibration to the arm
|
Higher Dose Vibration
n=15 Participants
RMBand high dose vibration
RMBand: Light-weight portable device that delivers higher dose vibration to the arm
|
|---|---|---|
|
Objective Measurement of Tremor Amplitude (mm).
Baseline
|
0.71 millimeters
Standard Deviation 0.82
|
0.43 millimeters
Standard Deviation 0.41
|
|
Objective Measurement of Tremor Amplitude (mm).
During vibration
|
0.76 millimeters
Standard Deviation 0.72
|
0.44 millimeters
Standard Deviation 0.31
|
|
Objective Measurement of Tremor Amplitude (mm).
Post vibration
|
0.70 millimeters
Standard Deviation 0.75
|
0.52 millimeters
Standard Deviation 0.47
|
Adverse Events
Lower Dose Vibration
Higher Dose Vibration
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lower Dose Vibration
n=15 participants at risk
RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration (frequency of 80 Hz) to the arm
|
Higher Dose Vibration
n=15 participants at risk
RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose (frequency of 160 Hz) vibration to the arm
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
muscle tightness
|
0.00%
0/15 • two hours, during time of study activities
|
6.7%
1/15 • Number of events 1 • two hours, during time of study activities
|
Additional Information
Dr. Ingrid Pretzer-Aboff
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60