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The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

Primary Purpose

Parkinson Disease, Essential Tremor, Dystonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
skin surface vibration
light skin surface vibration- SHAM
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Essential tremor, Dystonia, Vibrotactile stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Norman Fixel Institute for Neurological Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Vibrotactile Continuous stimulation

Vibrotactile Intermittent stimulation

Vibrotactile Sham

Arm Description

Continuous stimulation

Intermittent stimulation

Sham stimulation

Outcomes

Primary Outcome Measures

Quantitative Tremor Assessment
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

Functional Dexterity Task (FDT)
Functional Dexterity Task (FDT): The FDT is a pegboard assessment of manual dexterity.
Reaction time task
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
Timed-up-and-go (TUG) gait task
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.

Full Information

First Posted
October 12, 2021
Last Updated
September 26, 2022
Sponsor
University of Florida
Collaborators
Parkinson's Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05106816
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Parkinson's Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Essential Tremor, Dystonia
Keywords
Parkinson Disease, Essential tremor, Dystonia, Vibrotactile stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All participants will undergo tremor measurements and perform motor control tasks at baseline and during continuous vibratory stimulation and sham stimulation.
Masking
ParticipantOutcomes Assessor
Masking Description
The research subjects will be blinded regarding stimulation or sham and specific stimulation settings. Walking will be scored by a blinded rater for number of freezing episodes and walking completion time in seconds in the timed up and go task.
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vibrotactile Continuous stimulation
Arm Type
Experimental
Arm Description
Continuous stimulation
Arm Title
Vibrotactile Intermittent stimulation
Arm Type
Experimental
Arm Description
Intermittent stimulation
Arm Title
Vibrotactile Sham
Arm Type
Sham Comparator
Arm Description
Sham stimulation
Intervention Type
Other
Intervention Name(s)
skin surface vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
light skin surface vibration- SHAM
Intervention Description
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 Outcome Measure Information:
Title
Quantitative Tremor Assessment
Description
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
Time Frame
Baseline up to immediately after the sham intervention
Secondary Outcome Measure Information:
Title
Functional Dexterity Task (FDT)
Description
Functional Dexterity Task (FDT): The FDT is a pegboard assessment of manual dexterity.
Time Frame
Baseline up to immediately after the sham intervention
Title
Reaction time task
Description
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
Time Frame
Baseline up to immediately after the sham intervention
Title
Timed-up-and-go (TUG) gait task
Description
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.
Time Frame
Baseline up to immediately after the sham intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher W Hess, MD
Organizational Affiliation
Norman Fixel Institute for Neurological Diseases, University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norman Fixel Institute for Neurological Diseases
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be published, but no PHI will be made available.
Citations:
PubMed Identifier
22048131
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.
Results Reference
background
PubMed Identifier
25371843
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.
Results Reference
background
PubMed Identifier
16720935
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.
Results Reference
background
PubMed Identifier
12039427
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.
Results Reference
background
PubMed Identifier
23939405
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.
Results Reference
background

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The Effects of Vibrotactile Stimulation in Patients With Movement Disorders

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