Vibrotactile Stimulation in Parkinson's Disease



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:1/25/2018
Start Date:May 2016
End Date:November 2016

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The purpose of this study is to examine the possibility of a new, non-invasive, non-drug
treatment for Parkinson's disease. The treatment involves gentle vibratory stimulation
delivered to the fingertips (called 'vibrotactile stimulation'). Along with the treatment,
participants will also undergo kinematic testing.

Patient will be phone screened and/or have a physical and neurological examination to
determine if it is appropriate for them to participate in this study. This testing includes
the Unified Parkinson's Disease Rating Scale, Part III (UPDRS III). Research assistants will
explain the study and obtain informed consent. There will be three consecutive days of
testing, as well as 2 follow up visits at 1 and 4 weeks. Visits include the following:
Patients will have sensors put on their hands, feet, and chest. These sensors measure their
movement while they perform kinematic tasks such as forward walking, wrist movements, and the
UPDRS III. Patients will also be given vibrotactile stimulation for a total of 4 hours
throughout the day. During this time, patients will be provided with books/movies as
entertainment, and they may move around freely. Patients will also be asked to complete
several questionnaires throughout the visits about their Parkinson's symptoms.

Inclusion Criteria:

1. Age at least 18 years of age.

2. Speaks and understands English.

3. A diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr Stage II or III

4. Able and willing to come to study visits (3 consecutive days, as well as 2 follow up
visits, at 1 and 4 weeks)

5. Able and willing to stop therapy during the daytime for the days they come to the
clinic for the study.

6. Have improvement in motor signs ON versus OFF dopaminergic medication.

7. If on medication, the patient should be on stable doses of Sinemet and/or Stalevo
(Carbidopa/Levodopa Parkinson's medication) as part of their medicinal regimen
(Patient does not need to be on medication to be included in the study).

Exclusion Criteria:

1. Subjects, who are pregnant, are capable of becoming pregnant, or who are breast
feeding.

2. Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage IV on medication
(non-ambulatory).

3. Have significant cognitive impairment and/or dementia, as determined by a neurologist
at the Stanford Movement Disorders Clinic.

4. Have an implanted electronic device such as a cardiac pacemaker/defibrillator or
medication pump.

5. Subjects who have an inability to comply with study follow-up visits.

6. Subjects who are unable to understand or sign the informed consent.

7. Have an MRI showing focal brain lesions that could indicate a non-idiopathic movement
disorder.

8. Have an active infection.

9. Require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic
stimulation (TMS) to treat a chronic condition.
We found this trial at
1
site
Stanford, California 94304
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mi
from
Stanford, CA
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