Parkinson Disease Clinical Trial
Official title:
The Effects of Vibrotactile Stimulation (Not Impossible Vibrohealth) on Motor Control and Symptoms in Patients With Movement Disorders
Verified date | September 2022 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 20, 2022 |
Est. primary completion date | September 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Norman Fixel Institute for Neurological Diseases | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Parkinson's Foundation |
United States,
Charcot JM. Vibratory therapeutics.--The application of rapid and continuous vibrations to the treatment of certain diseases of the nervous system. 1892. J Nerv Ment Dis. 2011 Nov;199(11):821-7. doi: 10.1097/NMD.0b013e31823899bc. — View Citation
Gaßner H, Janzen A, Schwirtz A, Jansen P. Random Whole Body Vibration over 5 Weeks Leads to Effects Similar to Placebo: A Controlled Study in Parkinson's Disease. Parkinsons Dis. 2014;2014:386495. doi: 10.1155/2014/386495. Epub 2014 Oct 13. — View Citation
Haas CT, Turbanski S, Kessler K, Schmidtbleicher D. The effects of random whole-body-vibration on motor symptoms in Parkinson's disease. NeuroRehabilitation. 2006;21(1):29-36. — View Citation
Jöbges EM, Elek J, Rollnik JD, Dengler R, Wolf W. Vibratory proprioceptive stimulation affects Parkinsonian tremor. Parkinsonism Relat Disord. 2002 Jan;8(3):171-6. — View Citation
Kapur SS, Stebbins GT, Goetz CG. Vibration therapy for Parkinson's disease: Charcot's studies revisited. J Parkinsons Dis. 2012;2(1):23-7. doi: 10.3233/JPD-2012-12079. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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