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Vibrotactile Stimulation in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vibrotactile Stimulation

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

Stanford Movement Disorders Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vibrotactile Stimulation Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Patients Reporting Any Adverse Effects

Questionnaire asks patients to record any adverse effects they experienced.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT02933476

First Posted

July 8, 2016

Last Updated

January 22, 2018

Sponsor

Stanford University

Collaborators

John A Blume Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02933476

Brief Title

Vibrotactile Stimulation in Parkinson's Disease

Official Title

Vibrotactile Stimulation in Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

John A Blume Foundation

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vibrotactile Stimulation Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Vibrotactile Stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Patients Reporting Any Adverse Effects

Description

Questionnaire asks patients to record any adverse effects they experienced.

Time Frame

1 Month

Secondary Outcome Measure Information:

Title

Unified Parkinson's Disease Rating Scale, Part III

Description

Time Frame

1 Month

Title

Root Mean Square Velocity

Description

Using gyroscopes to track patient movement testing, root mean square velocity (Vrms) of of the wrist during repetitive wrist flexion extension task was obtained.

Time Frame

1 Month

Title

Gait Asymmetry

Description

Time Frame

1 Month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helen Bronte-Stewart, MD, MS

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Movement Disorders Clinic

City

Stanford

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24976001

Citation

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.

Results Reference

background

PubMed Identifier

12905037

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. doi: 10.1007/s00422-003-0425-7. Epub 2003 Jul 14.

Results Reference

background

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Vibrotactile Stimulation in Parkinson's Disease

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