Parkinson's Disease
Conditions
Brief summary
The purpose of this study is to examine the possibility of a new, non-invasive, non-drug treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment, participants will also undergo kinematic testing.
Detailed description
Patient will be phone screened and/or have a physical and neurological examination to determine if it is appropriate for them to participate in this study. This testing includes the Unified Parkinson's Disease Rating Scale, Part III (UPDRS III). Research assistants will explain the study and obtain informed consent. There will be three consecutive days of testing, as well as 2 follow up visits at 1 and 4 weeks. Visits include the following: Patients will have sensors put on their hands, feet, and chest. These sensors measure their movement while they perform kinematic tasks such as forward walking, wrist movements, and the UPDRS III. Patients will also be given vibrotactile stimulation for a total of 4 hours throughout the day. During this time, patients will be provided with books/movies as entertainment, and they may move around freely. Patients will also be asked to complete several questionnaires throughout the visits about their Parkinson's symptoms.
Interventions
DEVICEVibrotactile Stimulation
The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.
Sponsors
John A Blume Foundation
Stanford University
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 at least 18 years of age. 2. Speaks and understands English. 3. A diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr Stage II or III 4. Able and willing to come to study visits (3 consecutive days, as well as 2 follow up visits, at 1 and 4 weeks) 5. Able and willing to stop therapy during the daytime for the days they come to the clinic for the study. 6. Have improvement in motor signs ON versus OFF dopaminergic medication. 7. If on medication, the patient should be on stable doses of Sinemet and/or Stalevo (Carbidopa/Levodopa Parkinson's medication) as part of their medicinal regimen (Patient does not need to be on medication to be included in the study).
Exclusion criteria
1. Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding. 2. Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage IV on medication (non-ambulatory). 3. Have significant cognitive impairment and/or dementia, as determined by a neurologist at the Stanford Movement Disorders Clinic. 4. Have an implanted electronic device such as a cardiac pacemaker/defibrillator or medication pump. 5. Subjects who have an inability to comply with study follow-up visits. 6. Subjects who are unable to understand or sign the informed consent. 7. Have an MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder. 8. Have an active infection. 9. Require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Reporting Any Adverse Effects | 1 Month | Questionnaire asks patients to record any adverse effects they experienced. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease Rating Scale, Part III | 1 Month | We used the motor portion of the Unified Parkinson's disease Rating Scale (UPDRS) and excluded rigidity and speech from the assessment. Overall range of the score for the motor portion (excluding rigidity and speech) range from 0 to 108, where 0= best possible outcome and 108= worst possible outcome. |
| Root Mean Square Velocity | 1 Month | Using gyroscopes to track patient movement testing, root mean square velocity (Vrms) of of the wrist during repetitive wrist flexion extension task was obtained. |
| Gait Asymmetry | 1 Month | Using data collected from inertial measurement unit (IMU) sensors on subject, we were able to measure gait asymmetry. For each subject, the swing time (SW) was calculated and averaged across strides for the left and right legs (SWL and SWR). We obtained gait asymmetry using the following: 100 x /ln(SWR/SWL)/. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit. |
Countries
United States
Participant flow
Pre-assignment details
6 subjects were enrolled, but data only collected for 5 subjects. (1 subject was enrolled but no baseline data was collected due to illness)
Participants by arm
| Arm | Count |
|---|---|
| Vibrotactile Stimulation Treatment All patients will receive the vibrotactile stimulation treatment. No deception will be used.
Vibrotactile Stimulation: The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Vibrotactile Stimulation Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 6.7 |
| Disease Duration | 5.718 years STANDARD_DEVIATION 2.694 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 4 Participants |
| Unified Parkinson's disease Rating Scale, Part III | 21 units on a scale STANDARD_DEVIATION 12.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Number of Patients Reporting Any Adverse Effects
Questionnaire asks patients to record any adverse effects they experienced.
Time frame: 1 Month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vibrotactile Stimulation Treatment | Number of Patients Reporting Any Adverse Effects | 0 Participants |
Secondary
Gait Asymmetry
Using data collected from inertial measurement unit (IMU) sensors on subject, we were able to measure gait asymmetry. For each subject, the swing time (SW) was calculated and averaged across strides for the left and right legs (SWL and SWR). We obtained gait asymmetry using the following: 100 x /ln(SWR/SWL)/. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.
Time frame: 1 Month
Population: One out of the five patients was on medication so was excluded from analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vibrotactile Stimulation Treatment | Gait Asymmetry | Average gait asymmetry at 1 month | 4.53 arb.units | Standard Deviation 5.51 |
| Vibrotactile Stimulation Treatment | Gait Asymmetry | Average gait asymmetry at baseline | 8.51 arb.units | Standard Deviation 5.66 |
p-value: <0.001ANOVA
Secondary
Root Mean Square Velocity
Using gyroscopes to track patient movement testing, root mean square velocity (Vrms) of of the wrist during repetitive wrist flexion extension task was obtained.
Time frame: 1 Month
Population: One out of the five patients was on medication so was excluded from analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vibrotactile Stimulation Treatment | Root Mean Square Velocity | Average Vrms at baseline | 350.637 deg/s | Standard Deviation 140.222 |
| Vibrotactile Stimulation Treatment | Root Mean Square Velocity | Average Vrms at 1 month | 456.736 deg/s | Standard Deviation 156.634 |
p-value: 0.008ANOVA
Secondary
Unified Parkinson's Disease Rating Scale, Part III
We used the motor portion of the Unified Parkinson's disease Rating Scale (UPDRS) and excluded rigidity and speech from the assessment. Overall range of the score for the motor portion (excluding rigidity and speech) range from 0 to 108, where 0= best possible outcome and 108= worst possible outcome.
Time frame: 1 Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vibrotactile Stimulation Treatment | Unified Parkinson's Disease Rating Scale, Part III | UPDRS III at Baseline | 21 units on a scale | Standard Deviation 12.8 |
| Vibrotactile Stimulation Treatment | Unified Parkinson's Disease Rating Scale, Part III | UPDRS III at 1 week from baseline | 21.8 units on a scale | Standard Deviation 11.7 |
| Vibrotactile Stimulation Treatment | Unified Parkinson's Disease Rating Scale, Part III | UPDRS III at 4 weeks from baseline | 20.8 units on a scale | Standard Deviation 14.8 |
Comparison: We compared off therapy UPDRS III scores at baseline to one and four weeks after stimulation.p-value: >0.05ANOVA