The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

University of Florida

Status: Completed

Conditions: Essential Tremor; Dystonia; Parkinson Disease

Treatments: Other: skin surface vibration; Other: light skin surface vibration- SHAM

Study type: Interventional

Funder types: Other

Identifiers

NCT05106816

202002167

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 3 patient groups

Vibrotactile Continuous stimulation

Experimental group

Description:

Continuous stimulation

Treatment:

Other: skin surface vibration

Vibrotactile Intermittent stimulation

Experimental group

Description:

Intermittent stimulation

Treatment:

Other: skin surface vibration

Vibrotactile Sham

Sham Comparator group

Description:

Sham stimulation

Treatment:

Other: light skin surface vibration- SHAM