Parkinson Disease
Conditions
Brief summary
This is a study to evaluate peripheral vibrotactile coordinated reset stimulation for Parkinson's disease seeks to explore the safety and efficacy of an experimental non-invasive method to aid in the symptoms of Parkinson's disease. The purpose of the study is to verify the safety and tolerability of non-painful sensory (tactile) vibratory stimulation delivered to the fingertips of patients with Parkinson's disease.
Detailed description
This study aims to evaluate the safety and efficacy of a non-invasive, experimental method to aid in the symptoms of Parkinson's disease. A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients. Vibrotactile coordinated reset (vCR) will help investigators compare durability and efficacy of the tactile stimulation to current medical therapy. Participants will receive vCR for a minimum of 3 months and a maximum of 13 and motor ability will be recorded. If the results of this study suggest that vibrotactile CR stimulation is safe and effective for the treatment of Parkinson's disease, this non-invasive treatment approach would have a substantial impact on Parkinson's disease.
Interventions
DEVICETactile Stimulation Glove
A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.
Sponsors
Peter Tass, MD, PhD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 and older 2. Diagnosis of idiopathic Parkinson's disease. 3. Levodopa responsiveness as defined by at least a 30% reduction in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor subscale (excluding tremor scores) in the ON vs off medication state. 4. Willing to participate in the vibrotactile stimulation sessions for 2 consecutive days initially and willing to return for follow-up visits 5. Able to provide informed consent. 6. Appropriate social support
Exclusion criteria
1. Hoehn and Yahr stage greater than 3 in the on medication state 2. Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication induced parkinsonism, vascular Parkinsonism 3. Any illness that in the investigator's opinion precludes participation in the study 4. Subjects unable to communicate with the investigator and staff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score | Baseline, 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levodopa Equivalent Daily Dose | Baseline, 3 months | 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. |
| Electroencephalography (EEG) Sensorimotor Relative Power Activity | Baseline, 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tactile Stimulation Glove Patient receive Tactile Stimulation Glove stimulation for a minimum of 3 months and a maximum of 13 months. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Tactile Stimulation Glove |
|---|---|
| Age, Continuous | 53.33 Years STANDARD_DEVIATION 10.78 |
| Electroencephalography (EEG) sensorimotor relative power activity | 0.079 percentage of total power STANDARD_DEVIATION 0.036 |
| Levodopa equivalent daily dose (LEDD) | 711.50 mg/day STANDARD_DEVIATION 207.85 |
| MDS-UPDRS Baseline | 38.33 units on a scale STANDARD_DEVIATION 5.93 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
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.
Time frame: Baseline, 3 months
Population: Participants who completed baseline and the 3 month follow up are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tactile Stimulation Glove | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score | Baseline | 38.33 score on a scale | Standard Deviation 5.93 |
| Tactile Stimulation Glove | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score | 3 months | 32.33 score on a scale | Standard Deviation 7.8 |
Secondary
Electroencephalography (EEG) Sensorimotor Relative Power Activity
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.
Time frame: Baseline, 3 months
Population: Participants who completed the baseline and 3 month EEG were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tactile Stimulation Glove | Electroencephalography (EEG) Sensorimotor Relative Power Activity | Baseline high beta relative power | 0.079 percentage of total power | Standard Deviation 0.036 |
| Tactile Stimulation Glove | Electroencephalography (EEG) Sensorimotor Relative Power Activity | 3 months high beta relative power | 0.058 percentage of total power | Standard Deviation 0.025 |
Secondary
Levodopa Equivalent Daily Dose
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.
Time frame: Baseline, 3 months
Population: Participants who completed baseline and the 3 month protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tactile Stimulation Glove | Levodopa Equivalent Daily Dose | Baseline LEDD | 711.50 mg/day | Standard Deviation 207.85 |
| Tactile Stimulation Glove | Levodopa Equivalent Daily Dose | 3 month LEDD | 644.83 mg/day | Standard Deviation 229.85 |