Back to resultsA Study of Neurofeedback for the Treatment of Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Training with Neurofeedback
The other Training with Neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Magnetoencephalography, Neurofeedback
Eligibility Criteria
Inclusion Criteria:
- Subjects with age more than 20
- Subjects obtained the consent
- Subjects with Parkinson disease and healthy subjects
Exclusion Criteria:
- The subjects who can not conduct the tasks
- Subjects with severe illness
- Subjects whom the experimenter think as in appropriate
- Subjects with implantable devices such as pacemaker
Sites / Locations
- Osaka UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Training with Neurofeedback
The other Training with Neurofeedback
Arm Description
Outcomes
Primary Outcome Measures
Alteration of Brain Activities
measured by magnetoencephalography
Secondary Outcome Measures
The raw score change from baseline in the Movement disorder society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part Ⅲ scores
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
The total score is the sum of the subscale scores for Part III and ranges from 0 (no disability) to 132 (total dependence).
Full Information
NCT ID
NCT03837548
First Posted
January 15, 2019
Last Updated
September 10, 2019
Sponsor
Osaka University
Collaborators
Japan Agency for Medical Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03837548
Brief Title
A Study of Neurofeedback for the Treatment of Parkinson's Disease
Official Title
A Phase 1 Double-Blind Crossover Comparative Study of Neurofeedback for the Treatment of Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osaka University
Collaborators
Japan Agency for Medical Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to reveal relationship between brain activities and the symptoms of Parkinson disease when a neurofeedback training was applied for them.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, Magnetoencephalography, Neurofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training with Neurofeedback
Arm Type
Experimental
Arm Title
The other Training with Neurofeedback
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Training with Neurofeedback
Intervention Description
Neurofeedback the brain activities by Magnetoencephalography
Intervention Type
Other
Intervention Name(s)
The other Training with Neurofeedback
Intervention Description
Neurofeedback the brain activities by Magnetoencephalography
Primary Outcome Measure Information:
Title
Alteration of Brain Activities
Description
measured by magnetoencephalography
Time Frame
At the time Immediately following the training
Secondary Outcome Measure Information:
Title
The raw score change from baseline in the Movement disorder society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part Ⅲ scores
Description
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
The total score is the sum of the subscale scores for Part III and ranges from 0 (no disability) to 132 (total dependence).
Time Frame
At the time Immediately following the training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with age more than 20
Subjects obtained the consent
Subjects with Parkinson disease and healthy subjects
Exclusion Criteria:
The subjects who can not conduct the tasks
Subjects with severe illness
Subjects whom the experimenter think as in appropriate
Subjects with implantable devices such as pacemaker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takufumi Yanagisawa, Ph.D.
Phone
+81-6-6879-3652
Email
tyanagisawa@nsurg.med.osaka-u.ac.jp
Facility Information:
Facility Name
Osaka University
City
Suita-City
State/Province
Osaka-fu
ZIP/Postal Code
5650871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takufumi Yanagisawa, Ph.D.
Phone
+81-6-6879-3652
Email
tyanagisawa@nsurg.med.osaka-u.ac.jp
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Neurofeedback for the Treatment of Parkinson's Disease
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