- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03837548
A Study of Neurofeedback for the Treatment of Parkinson's Disease
A Phase 1 Double-Blind Crossover Comparative Study of Neurofeedback for the Treatment of Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Takufumi Yanagisawa, Ph.D.
- Phone Number: +81-6-6879-3652
- Email: tyanagisawa@nsurg.med.osaka-u.ac.jp
Study Locations
-
-
Osaka-fu
-
Suita-City, Osaka-fu, Japan, 5650871
- Recruiting
- Osaka University
-
Contact:
- Takufumi Yanagisawa, Ph.D.
- Phone Number: +81-6-6879-3652
- Email: tyanagisawa@nsurg.med.osaka-u.ac.jp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training with Neurofeedback
|
Neurofeedback the brain activities by Magnetoencephalography
|
Experimental: The other Training with Neurofeedback
|
Neurofeedback the brain activities by Magnetoencephalography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alteration of Brain Activities
Time Frame: At the time Immediately following the training
|
measured by magnetoencephalography
|
At the time Immediately following the training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The raw score change from baseline in the Movement disorder society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part Ⅲ scores
Time Frame: At the time Immediately following the training
|
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). |
At the time Immediately following the training
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18027-2
- UMIN000032937 (Registry Identifier: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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