Vibrotactile Stimulation in Parkinson's Disease

NCT02933476 | Completed Results

• 1 other identifier: IRB 35238
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Number of Patients Reporting Any Adverse Effects

  Questionnaire asks patients to record any adverse effects they experienced.

  1 Month

Secondary Outcomes (3)

• Unified Parkinson's Disease Rating Scale, Part III

  1 Month

• Root Mean Square Velocity

  1 Month

• Gait Asymmetry

  1 Month

Study Arms (1)

Vibrotactile Stimulation Treatment

EXPERIMENTAL

All patients will receive the vibrotactile stimulation treatment. No deception will be used.

Device: Vibrotactile Stimulation

Interventions

Vibrotactile Stimulation DEVICE

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.

Vibrotactile Stimulation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at least 18 years of age.
• Speaks and understands English.
• A diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr Stage II or III
• Able and willing to come to study visits (3 consecutive days, as well as 2 follow up visits, at 1 and 4 weeks)
• Able and willing to stop therapy during the daytime for the days they come to the clinic for the study.
• Have improvement in motor signs ON versus OFF dopaminergic medication.
• 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).

You may not qualify if:

• Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
• Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage IV on medication (non-ambulatory).
• Have significant cognitive impairment and/or dementia, as determined by a neurologist at the Stanford Movement Disorders Clinic.
• Have an implanted electronic device such as a cardiac pacemaker/defibrillator or medication pump.
• Subjects who have an inability to comply with study follow-up visits.
• Subjects who are unable to understand or sign the informed consent.
• Have an MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder.
• Have an active infection.
• Require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.

Sponsors & Collaborators

• Stanford University: lead
• John A Blume Foundation: collaborator

Study Sites (1)

Stanford Movement Disorders Clinic

Stanford, California, 94304, United States

Location

Related Publications (2)

• 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.

  PMID: 24976001 BACKGROUND

• 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.

  PMID: 12905037 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Raumin Neuville
• Organization: Stanford School of Medicine

raumin@stanford.edu

6507236709

Study Officials

• Helen Bronte-Stewart, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: October 14, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)