Clinical trial NCT05106816: The Effects of Vibrotactile Stimulation in Patients With Movement Disorders
Official title: The Effects of Vibrotactile Stimulation (Not Impossible Vibrohealth) on Motor Control and Symptoms in Patients With Movement Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Essential Tremor
Dystonia
Keywords: Parkinson Disease
Essential tremor
Dystonia
Vibrotactile stimulation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Parkinson's Foundation
First posted: 2021-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will undergo tremor measurements and perform motor control tasks at baseline and during continuous vibratory stimulation and sham stimulation.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quantitative Tremor Assessment
timeFrame: Baseline up to immediately after the sham intervention
Secondary outcomes:
measure: Functional Dexterity Task (FDT)
timeFrame: Baseline up to immediately after the sham intervention
measure: Reaction time task
timeFrame: Baseline up to immediately after the sham intervention
measure: Timed-up-and-go (TUG) gait task
timeFrame: Baseline up to immediately after the sham intervention
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Norman Fixel Institute for Neurological Diseases
state: Florida
Study officials:
affiliation: Norman Fixel Institute for Neurological Diseases, University of Florida
name: Christopher W Hess, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: 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.
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.