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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03837548
• Other study ID #: 18027-2
• Secondary ID: UMIN000032937
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2019
• Source: Osaka University
• Contact: Takufumi Yanagisawa, Ph.D.
• Phone: +81-6-6879-3652
• Email: tyanagisawa[@]nsurg.med.osaka-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Japan	Osaka University	Suita-City	Osaka-fu

Sponsors (2)

Lead Sponsor	Collaborator
Osaka University	Japan Agency for Medical Research and Development

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alteration of Brain Activities	measured by magnetoencephalography	At the time Immediately following the training
Secondary	The raw score change from baseline in the Movement disorder society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part ? 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).	At the time Immediately following the training