An interventional study of skin surface vibration and light skin surface vibration- SHAM in Parkinson Disease, Essential Tremor and Dystonia, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-27.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 40 is close to the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
Continuous stimulation
Other: skin surface vibration
Intermittent stimulation
Other: skin surface vibration
Sham stimulation
Other: light skin surface vibration- SHAM
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.
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.
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
Time frame: Baseline up to immediately after the sham intervention
Functional Dexterity Task (FDT)
Functional Dexterity Task (FDT): The FDT is a pegboard assessment of manual dexterity.
Time frame: 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
Time frame: 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.
Time frame: Baseline up to immediately after the sham intervention
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Plan to share: No — Data will be published, but no PHI will be made available.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University of Florida