Vibrotactile Stimulation in Parkinson's Disease

NCT ID: NCT02933476

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-11-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vibrotactile Stimulation Treatment

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

Group Type: EXPERIMENTAL

Vibrotactile Stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

John A Blume Foundation

UNKNOWN

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Helen M. Bronte-Stewart

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Bronte-Stewart, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Movement Disorders Clinic

Stanford, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24976001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12905037 (View on PubMed)

Other Identifiers

IRB 35238

Identifier Type: -

Identifier Source: org_study_id