Evaluation of Using Vibrotactile Coordinated Reset for Management of Parkinson's Disease



Status:Not yet recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:April 1, 2019
End Date:September 30, 2019

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A Prospective, Randomized, Staggered-onset, Double Blinded, Sham-Controlled Study to Evaluate Peripheral Vibrotactile Coordinated Reset (CR) Stimulation for Parkinson's Disease

This is a study to evaluate peripheral vibrotactile coordinated reset stimulation for
Parkinson's disease seeks to explore the safety and efficacy of an experimental non-invasive
method to aid in the symptoms of Parkinson's disease. The purpose of the study is to verify
the safety and tolerability of non-painful sensory (tactile) vibratory stimulation delivered
to the fingertips of patients with Parkinson's disease.

This study aims to evaluate the safety and efficacy of a non-invasive, experimental method to
aid in the symptoms of Parkinson's disease. A glove device produces non-painful sensory
(tactile) vibratory stimulation to the fingertips of Parkinson's patients. Participants will
either be randomized to receive the real stimulation, or fake ("sham") stimulation. This will
help investigators compare durability and efficacy of the tactile stimulation to current
medical therapy. Participants randomized to the "sham" arm will be allowed to receive the
real stimulation after 3 months of follow-up. All patients will be followed for total of 6
months (both real and sham stimulation groups). If the results of this study suggest that
vibrotactile CR stimulation is safe and effective for the treatment of Parkinson's disease,
this non-invasive treatment approach would have a substantial impact on Parkinson's disease.

Inclusion Criteria:

1. Age 18 and older

2. Diagnosis of idiopathic Parkinson's disease.

3. Levodopa responsiveness as defined by at least a 30% reduction in MDS-UPDRS motor
subscale (excluding tremor scores) in the ON vs OFF medication state.

4. Willing to participate in the vibrotactile stimulation sessions for 2 consecutive days
initially and willing to return for follow-up visits

5. Able to provide informed consent.

6. Appropriate social support

Exclusion Criteria:

1. Hoehn and Yahr stage greater than 3 in the on medication state

2. Presence of other forms of non-idiopathic parkinsonism, including but not limited to
atypical parkinsonism, medication induced parkinsonism, vascular Parkinsonism

3. Any illness that in the investigator's opinion precludes participation in the study

4. Subjects unable to communicate with the investigator and staff
We found this trial at
1
site
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Phone: 650-498-0817
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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from
Stanford, CA
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