Clinical trial NCT02933476: Vibrotactile Stimulation in Parkinson's Disease
Official title: Vibrotactile Stimulation in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: John A Blume Foundation
First posted: 2016-10-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients Reporting Any Adverse Effects
timeFrame: 1 Month
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale, Part III
timeFrame: 1 Month
measure: Root Mean Square Velocity
timeFrame: 1 Month
measure: Gait Asymmetry
timeFrame: 1 Month
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Movement Disorders Clinic
state: California
Study officials:
affiliation: Stanford University
name: Helen Bronte-Stewart, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adamchic I, Hauptmann C, Barnikol UB, Pawelczyk N, Popovych O, Barnikol TT, Silchenko A, Volkmann J, Deuschl G, Meissner WG, Maarouf M, Sturm V, Freund HJ, Tass PA. Coordinated reset neuromodulation for Parkinson's disease: proof-of-concept study. Mov Disord. 2014 Nov;29(13):1679-84. doi: 10.1002/mds.25923. Epub 2014 Jun 28.
citation: Tass PA. A model of desynchronizing deep brain stimulation with a demand-controlled coordinated reset of neural subpopulations. Biol Cybern. 2003 Aug;89(2):81-8. doi: 10.1007/s00422-003-0425-7. Epub 2003 Jul 14.