Trial Outcomes & Findings for Evaluation of Using Vibrotactile Coordinated Reset for Management of Parkinson's Disease (NCT NCT03857867)
NCT ID: NCT03857867
Last Updated: 2021-12-21
Results Overview
The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms.
TERMINATED
NA
7 participants
Baseline, 3 months
2021-12-21
Participant Flow
Participant milestones
| Measure |
Tactile Stimulation Glove
Patient receive Tactile Stimulation Glove stimulation for a minimum of 3 months and a maximum of 13 months. The glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Tactile Stimulation Glove
Patient receive Tactile Stimulation Glove stimulation for a minimum of 3 months and a maximum of 13 months. The glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.
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|---|---|
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Overall Study
Physician Decision
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1
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Baseline Characteristics
5 out of 6 participants EEG were able to be analyzed. One patients EEG was not recorded due to covid-19
Baseline characteristics by cohort
| Measure |
Tactile Stimulation Glove
n=6 Participants
Patient receive Tactile Stimulation Glove stimulation for a minimum of 3 months and a maximum of 13 months.
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|---|---|
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Age, Continuous
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53.33 Years
STANDARD_DEVIATION 10.78 • n=6 Participants
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Sex: Female, Male
Female
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2 Participants
n=6 Participants
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Sex: Female, Male
Male
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4 Participants
n=6 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=6 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=6 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=6 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=6 Participants
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Race (NIH/OMB)
White
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5 Participants
n=6 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=6 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=6 Participants
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Region of Enrollment
United States
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6 participants
n=6 Participants
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MDS-UPDRS Baseline
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38.33 units on a scale
STANDARD_DEVIATION 5.93 • n=6 Participants
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Levodopa equivalent daily dose (LEDD)
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711.50 mg/day
STANDARD_DEVIATION 207.85 • n=6 Participants
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Electroencephalography (EEG) sensorimotor relative power activity
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0.079 percentage of total power
STANDARD_DEVIATION 0.036 • n=5 Participants • 5 out of 6 participants EEG were able to be analyzed. One patients EEG was not recorded due to covid-19
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PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: Participants who completed baseline and the 3 month follow up are included in the analysis.
The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms.
Outcome measures
| Measure |
Tactile Stimulation Glove
n=6 Participants
Patients receive Tactile Stimulation for 3 months
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|---|---|
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Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
Baseline
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38.33 score on a scale
Standard Deviation 5.93
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Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
3 months
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32.33 score on a scale
Standard Deviation 7.80
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SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Participants who completed baseline and the 3 month protocol were included in the analysis.
Levodopa equivalent daily dose (LEDD) was measured at baseline and after 3 months of vibrotactile coordinated reset therapy. LEDD is calculated as a sum of each Parkinson's medication.
Outcome measures
| Measure |
Tactile Stimulation Glove
n=6 Participants
Patients receive Tactile Stimulation for 3 months
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|---|---|
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Levodopa Equivalent Daily Dose
Baseline LEDD
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711.50 mg/day
Standard Deviation 207.85
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Levodopa Equivalent Daily Dose
3 month LEDD
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644.83 mg/day
Standard Deviation 229.85
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SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Participants who completed the baseline and 3 month EEG were included in the analysis
Measure Description: Baseline EEG was recorded. EEG source estimation was computed using Standardized low-resolution brain electromagnetic tomography analysis (sLORETA) and was restricted to the sensorimotor region. Power spectral density (PSD) was calculated for each frequency band (Delta: 2-4 Hz; Theta: 5-7 Hz; Alpha: 8-12 Hz; Low Beta: 13-16 Hz; Mid Beta: 17-20 Hz; High Beta: 21-30 Hz; Gamma: 31-50 Hz). Relative power (RP) was calculated by taking the sum of each frequency and dividing it by the total power (2-50 Hz) expressed as a percentage. High beta power was the frequency band of interest for analysis.
Outcome measures
| Measure |
Tactile Stimulation Glove
n=5 Participants
Patients receive Tactile Stimulation for 3 months
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|---|---|
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Electroencephalography (EEG) Sensorimotor Relative Power Activity
Baseline high beta relative power
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0.079 percentage of total power
Standard Deviation 0.036
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Electroencephalography (EEG) Sensorimotor Relative Power Activity
3 months high beta relative power
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0.058 percentage of total power
Standard Deviation 0.025
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Adverse Events
Tactile Stimulation Glove
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place