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A Study of Neurofeedback for the Treatment of Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03837548
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Japan Agency for Medical Research and Development
Information provided by (Responsible Party):
Osaka University

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Training with Neurofeedback Other: The other Training with Neurofeedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Double-Blind Crossover Comparative Study of Neurofeedback for the Treatment of Parkinson's Disease
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Training with Neurofeedback Other: Training with Neurofeedback
Neurofeedback the brain activities by Magnetoencephalography

Experimental: The other Training with Neurofeedback Other: The other Training with Neurofeedback
Neurofeedback the brain activities by Magnetoencephalography




Primary Outcome Measures :
  1. Alteration of Brain Activities [ Time Frame: At the time Immediately following the training ]
    measured by magnetoencephalography


Secondary Outcome Measures :
  1. 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).




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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837548


Contacts
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Contact: Takufumi Yanagisawa, Ph.D. +81-6-6879-3652 tyanagisawa@nsurg.med.osaka-u.ac.jp

Locations
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Japan
Osaka University Recruiting
Suita-City, Osaka-fu, Japan, 5650871
Contact: Takufumi Yanagisawa, Ph.D.    +81-6-6879-3652    tyanagisawa@nsurg.med.osaka-u.ac.jp   
Sponsors and Collaborators
Osaka University
Japan Agency for Medical Research and Development

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Responsible Party: Osaka University
ClinicalTrials.gov Identifier: NCT03837548     History of Changes
Other Study ID Numbers: 18027
UMIN000032937 ( Registry Identifier: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) )
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Osaka University:
Parkinson's Disease
Magnetoencephalography
Neurofeedback

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases