The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

Study Overview
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Brief Summary
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Vibration applied to the skin has been anecdotally reported to potentially improve motor control in patients with movement disorders including Parkinson's disease, however few devices have been studied formally. In this study, the investigators will test the effect of skin surface vibration applied non-invasively to patients with movement disorders to determine if there are any beneficial effects on common tasks of motor control and/or abnormal motor symptoms in patients with Parkinson's disease (PD), essential tremor (ET), and dystonia.

Detailed Description
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This study is to evaluate the feasibility, reliability, and clinical effects of Non-invasive vibrotactile stimulation (VTS) on basic tasks of motor control and on the motor symptoms of patients with movement disorders. VTS Settings will include continuous stimulation, intermittent stimulation during walking, and sham stimulation. The investigators will recruit 30 patients with PD who are between the ages of 18-80 years old and independently living in the community. The investigators will additionally recruit up to 5 patients with ET and up to 5 patients with dystonia.

Official Title
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The Effects of Vibrotactile Stimulation (Not Impossible Vibrohealth) on Motor Control and Symptoms in Patients With Movement Disorders

Conditions
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Parkinson Disease, Essential Tremor, Dystonia

Intervention / Treatment
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* Other: skin surface vibration
* Other: light skin surface vibration- SHAM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 and able to provide informed consent. Have a diagnosis of Parkinson's disease, essential tremor, or cervical dystonia made by a movement disorders specialist. Medically optimized without planned medication changes for the duration of the study. For patients with ET, they will have a score of at least 2 on items 5 and 6 of the Fahn-Tolosa-Marin (FTM) Tremor Rating Scale. For patients with dystonia, they will have abnormal dystonic postures of the head and not isolated head tremor Exclusion Criteria: The presence of additional neurologic diseases, that might confound testing or the coexistence of PD and ET together (action tremor that was present prior to the development of parkinsonism). Symptoms of peripheral neuropathy at the wrist (reduced vibratory, pinprick, or temperature sensation) Montreal cognitive assessment (MoCA) score < 20 or previously documented dementia Unable to walk without a walking aid (e.g. cane, stick, walker)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants will undergo tremor measurements and perform motor control tasks at baseline and during continuous vibratory stimulation and sham stimulation.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrotactile Continuous stimulation<br>Continuous stimulation | Other: skin surface vibration<br>* This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones.<br>|
| Experimental: Vibrotactile Intermittent stimulation<br>Intermittent stimulation | Other: skin surface vibration<br>* This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones.<br>|
| Sham Comparator: Vibrotactile Sham<br>Sham stimulation | Other: light skin surface vibration- SHAM<br>* This study will use four vibrating devices worn on each of the limbs. The devices are paired with a cell phone application (to be used solely by research investigators) that adjusts the vibration settings. The intensity of the vibration produced by the device is far less than that produced by commercially available massagers used for relaxation using similar technology. The sensor in the device is a tri-axial accelerometer and gyroscope that measures position using the same technology as smartphones. Worn at the lowest frequency will simulate the active arms with no potential change in symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Tremor Assessment | An external accelerometer will be adhered to the skin of the dorsum of the hand and will be used to quantify displacement of the hand due to tremor in the following conditions: 1. Sitting at rest 2. Sitting with both arms outstretched 3. Sitting at rest while performing a distracting cognitive task 4. Transition from rest to posture (arms held directly in front of patient) for 10 seconds | Baseline up to immediately after the sham intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Dexterity Task (FDT) | Functional Dexterity Task (FDT): The FDT is a pegboard assessment of manual dexterity. | Baseline up to immediately after the sham intervention | 
| Reaction time task | Subjects will look at a central fixation symbol on computer screen and press a computer keyboard/mouse button when the GO signal appears. The time between the onset of the fixation cross and the green GO signal will vary so that the onset of the GO signal will not be predictable. The time between appearance of the GO signal and recorded keyboard response will be recorded as reaction time | Baseline up to immediately after the sham intervention | 
| Timed-up-and-go (TUG) gait task | Subjects are asked to stand up from a chair, walk 3 meters to a horizontal line marked with red tape on the floor, turn around, walk back and sit down, at a comfortable pace. this task will be performed on an the instrumented mat that measures gait characteristics. | Baseline up to immediately after the sham intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Essential tremor, Dystonia, Vibrotactile stimulation