Vibrotactile Stimulation in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Vibrotactile Stimulation in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933476
• Other study ID #: IRB 35238
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: January 22, 2018
• Start date: May 2016
• Est. completion date: November 2016

Study information

• Verified date: January 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Movement Disorders Clinic	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	John A Blume Foundation

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Epub 2003 Jul 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Reporting Any Adverse Effects	Questionnaire asks patients to record any adverse effects they experienced.	1 Month
Secondary	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
Secondary	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
Secondary	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