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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05106816
Other study ID # 202002167
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2021
Est. completion date September 20, 2022

Study information

Verified date September 2022
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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)

Study Design


Intervention

Other:
skin surface vibration
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.
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. Worn at the lowest frequency will simulate the active arms with no potential change in symptoms.

Locations

Country Name City State
United States Norman Fixel Institute for Neurological Diseases Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida Parkinson's Foundation

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

Outcome

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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