The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

September 26, 2022 updated by: University of Florida

The Effects of Vibrotactile Stimulation (Not Impossible Vibrohealth) on Motor Control and Symptoms 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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32608
        • Norman Fixel Institute for Neurological Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vibrotactile Continuous stimulation
Continuous stimulation
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.
Experimental: Vibrotactile Intermittent stimulation
Intermittent stimulation
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.
Sham Comparator: Vibrotactile Sham
Sham stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline up to immediately after the sham intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to immediately after the sham intervention
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
Baseline up to immediately after the sham intervention
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.
Baseline up to immediately after the sham intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Christopher W Hess, MD, Norman Fixel Institute for Neurological Diseases, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2021

Primary Completion (Actual)

September 20, 2022

Study Completion (Actual)

September 20, 2022

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

October 29, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be published, but no PHI will be made available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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