Skip to main content
OpenTrials
Completed

NCT Number: NCT05106816

The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Dystonia Essential Tremor Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

skin surface vibration

Other

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

Other

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.

Primary outcomes

  1. 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:

    • 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 outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Parkinson's Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2021
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.