The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

Not Applicable

Completed

• Conditions: Dystonia; Essential Tremor; Parkinson Disease
• Interventions: Other: skin surface vibration; Other: light skin surface vibration- SHAM

• Registration Number: NCT05106816
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study Start: 2021-10-07
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-04
• Status Verified: 2022-09
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vibrotactile Continuous stimulation	skin surface vibration	Continuous stimulation
Vibrotactile Intermittent stimulation	skin surface vibration	Intermittent stimulation
Vibrotactile Sham	light skin surface vibration- SHAM	Sham stimulation

Primary Outcome Measures

Name	Time	Method
Quantitative Tremor Assessment	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: * 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

Secondary Outcome Measures

Name	Time	Method
Functional Dexterity Task (FDT)	Baseline up to immediately after the sham intervention	Functional Dexterity Task (FDT): The FDT is a pegboard assessment of manual dexterity.
Timed-up-and-go (TUG) gait task	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.
Reaction time task	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

Trial Locations

Locations (1)

Norman Fixel Institute for Neurological Diseases; 🇺🇸 Gainesville, Florida, United States