Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on advance stage Parkinson's symptoms. VCR will be administered with a device called the vibrotactile axon Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. Patients will be followed for two years.

Official Title
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Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Vibrotactile coordinated reset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at the time of enrollment: 35 - 90 years Idiopathic Parkinson's Symptoms between hoehn and yahr stages 2 to 4 Fluent in English If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording Appropriate social support if required during an off state. Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes. Exclusion Criteria: Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies Any current drug or alcohol abuse. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators. Pregnancy, breast-feeding or wanting to become pregnant Physical limitations unrelated to PD that would affect motor ratings Craniotomy with the exception of burr holes. Brain surgery Patient is unable to communicate properly with staff (i.e., severe speech problems) Excessive drooling A type of hairstyle that would impede the use of an EEG cap

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrotactile Coordinated Reset (vCR)<br>Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain. | Device: Vibrotactile coordinated reset<br>* The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Advanced stage Parkinson's disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III change from baseline, 6 months, 12 months, 18 months and 24 months. | This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months | LEDD is calculated as a daily sum of levodopa in each Parkinson's medication | 24 months | 
| Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline, 6 months, 12 months, 18 months and 24 months. | The PD Quality of Life Questionnaire-39 (PDQ-39) is a self-report questionnaire that examines health related difficulties specific to PD in eight quality of life categories within the last month. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100, with higher % indicating more health problems. | 24 months | 
| Freezing of gait questionnaire (FOG) change from baseline, 6 months, 12 months, 18 months and 24 months. | The FOGQ assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's Disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects (e.g., turning). The FOG is comprised of 6 questions measured on a 0 to 4 scale (where 0 is normal and 4 represents severe abnormalities). The scores are summed together with 0 representing the best possible score and 24 representing the worst possible score. | 24 months | 
| Vibratory temporal discrimination task (VTDT) change from baseline, 6 months, 12 months, 18 months and 24 months. | The vibratory temporal discrimination task (VTDT) consists of two vibratory bursts, with one burst delivered to the index finger and one burst to the middle finger. This procedure will be performed on the right and left hand separately. The patient is instructed to judge if he/she felt a delay between the two vibratory bursts. The inner stimulus interval (ISI) is RECORDED when the participant indicates that they can feel a difference in time between the two vibrations. The ISI can range from 10ms-110 ms | 24 months | 
| Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline, 6 months, 12 months, 18 months and 24 months. | The MDS-UPDRS part 1 focuses on non-motor symptoms, such as dementia, depression, and psychosis. The total summed score ranges from 0-52 with higher scores indicating increased non-motor impairment. | 24 months | 
| Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline, 6 months, 12 months, 18 months and 24 months. | The MDS-UPDRS part 2 focuses on the patient's ability to perform daily motor activities including dressing, grooming, and using utensils. The total summed score ranges from 0-52 with higher scores indicating increased daily motor impairment. | 24 months | 
| Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change from baseline, 6 months, 12 months, 18 months and 24 months. | The MDS-UPDRS 4 focuses on Measures the complications of treatment, e.g. dyskinesias and motor fluctuations. The total summed score ranges from 0-24 with higher scores indicating increased motor complications. | 24 months | 
| Communicative Participation Item Bank (CPIB; Short Form) change from baseline, 6 months, 12 months, 18 months and 24 months. | The CPIB is a questionnaire that measures speech complications. The questionnaire is scored from 0 to 30, with a higher score indicating increased speech difficulties. | 24 months | 
| Voice Handicap Index (VHI-10) change from baseline, 6 months, 12 months, 18 months and 24 months. | This questionnaire can be filled out by patients and assesses the impact that voice problems and limitations have on the individual's overall daily function. Questionnaire is scored from 0 to 40, with a higher score indicating increased speech difficulties. | 24 months | 
| Spontaneous EEG beta band power change from baseline, 6 months, 12 months, 18 months and 24 months. | Patients will be recorded while receiving vibrotactile stimulation. The Beta Band (13-30Hz) power spectral density (PSD) will be of interest. The units of the power spectral density are micro-Volts-squared per Hz. Increases in Beta band PSD are associated with motor impairment in Parkinson's disease, while decreases in the beta band are associated with motor improvement. | 24 months | 
| Parkinson's disease cognitive functional rating scale (PD-CFRS) change from baseline, 6 months, 12 months, 18 months and 24 months. | The PD-CFRS capture subjective daily functional cognitive decline among patients with Parkinson's disease over the past 2 weeks. The scale ranges from 0 to 24, with higher scores indicative of cognitive decline. | 24 months | 
| Parkinson's Disease-Cognitive Rating Scale (PDCRS) change from baseline, 6 months, 12 months, 18 months and 24 months. | The PDCRS is a cognitive test designed to designed to cover the full spectrum of cognitive defects associated with Parkinson's Disease. The total test score ranges from 0 - 134, with higher scores indicating less cognitive impairment. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive