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

September 10, 2019 updated by: Osaka University

A Phase 1 Double-Blind Crossover Comparative Study of Neurofeedback for the Treatment of Parkinson's Disease

This study aims to reveal relationship between brain activities and the symptoms of Parkinson disease when a neurofeedback training was applied for them.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Osaka University

Collaborators

Japan Agency for Medical Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

February 9, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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