Vibrotactile Stimulation in Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT02933476
• Recruitment Status: Completed
• First Posted: October 14, 2016
• Results First Posted: January 23, 2018
• Last Update Posted: January 23, 2018
• Sponsor: Stanford University
• Collaborator: John A Blume Foundation
• Information provided by (Responsible Party): Helen M. Bronte-Stewart, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Device: Vibrotactile Stimulation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vibrotactile Stimulation in Parkinson's Disease
• Study Start Date: May 2016
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: November 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Reporting Any Adverse Effects [ Time Frame: 1 Month ]
   Questionnaire asks patients to record any adverse effects they experienced.

Secondary Outcome Measures :

1. Unified Parkinson's Disease Rating Scale, Part III [ Time Frame: 1 Month ]
   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.
2. Root Mean Square Velocity [ Time Frame: 1 Month ]
   Using gyroscopes to track patient movement testing, root mean square velocity (Vrms) of of the wrist during repetitive wrist flexion extension task was obtained.
3. Gait Asymmetry [ Time Frame: 1 Month ]
   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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, California

Stanford Movement Disorders Clinic

Stanford, California, United States, 94304

Sponsors and Collaborators

Stanford University

John A Blume Foundation

Investigators

• Principal Investigator: Helen Bronte-Stewart, MD, MS; Stanford University

More Information

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. Epub 2003 Jul 14.

• Responsible Party: Helen M. Bronte-Stewart, Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT02933476
• Other Study ID Numbers: IRB 35238
• First Posted: October 14, 2016
• Results First Posted: January 23, 2018
• Last Update Posted: January 23, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases