Vibrotactile Stimulation in Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Vibrotactile Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford Movement Disorders Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibrotactile Stimulation Treatment; All patients will receive the vibrotactile stimulation treatment. No deception will be used.	Device: Vibrotactile Stimulation; The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Reporting Any Adverse Effects	Questionnaire asks patients to record any adverse effects they experienced.	1 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's Disease Rating Scale, Part III	We used the motor portion of the Unified Parkinson's disease Rating Scale (UPDRS) and excluded rigidity and speech from the assessment. Overall range of the score for the motor portion (excluding rigidity and speech) range from 0 to 108, where 0= best possible outcome and 108= worst possible outcome.	1 Month
Root Mean Square Velocity	Using gyroscopes to track patient movement testing, root mean square velocity (Vrms) of of the wrist during repetitive wrist flexion extension task was obtained.	1 Month
Gait Asymmetry	Using data collected from inertial measurement unit (IMU) sensors on subject, we were able to measure gait asymmetry. For each subject, the swing time (SW) was calculated and averaged across strides for the left and right legs (SWL and SWR). We obtained gait asymmetry using the following: 100 x /ln(SWR/SWL)/. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.	1 Month

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: John A Blume Foundation
• Investigators: Principal Investigator: Helen Bronte-Stewart, MD, MS, Stanford University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: IRB 35238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No