The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106816
• Other study ID #: 202002167
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Essential Tremor
• Movement Disorders
• Parkinson Disease
• Tremor

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