- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05106816
The Effects of Vibrotactile Stimulation in Patients With Movement Disorders
The Effects of Vibrotactile Stimulation (Not Impossible Vibrohealth) on Motor Control and Symptoms in Patients With Movement Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608
- Norman Fixel Institute for Neurological Diseases
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vibrotactile Continuous stimulation
Continuous stimulation
|
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.
|
Experimental: Vibrotactile Intermittent stimulation
Intermittent stimulation
|
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.
|
Sham Comparator: Vibrotactile Sham
Sham stimulation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative Tremor Assessment
Time Frame: Baseline up to immediately after the sham intervention
|
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:
|
Baseline up to immediately after the sham intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Dexterity Task (FDT)
Time Frame: Baseline up to immediately after the sham intervention
|
Functional Dexterity Task (FDT): The FDT is a pegboard assessment of manual dexterity.
|
Baseline up to immediately after the sham intervention
|
Reaction time task
Time Frame: Baseline up to immediately after the sham intervention
|
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
Time Frame: Baseline up to immediately after the sham intervention
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher W Hess, MD, Norman Fixel Institute for Neurological Diseases, University of Florida
Publications and helpful links
General Publications
- 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.
- 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. No abstract available.
- 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.
- Jobges EM, Elek J, Rollnik JD, Dengler R, Wolf W. Vibratory proprioceptive stimulation affects Parkinsonian tremor. Parkinsonism Relat Disord. 2002 Jan;8(3):171-6. doi: 10.1016/s1353-8020(01)00016-5.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202002167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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