NCT03837548

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

September 11, 2019

Status Verified

August 1, 2019

Enrollment Period

2.8 years

First QC Date

January 15, 2019

Last Update Submit

September 10, 2019

Conditions

Keywords

Parkinson's DiseaseMagnetoencephalographyNeurofeedback

Outcome Measures

Primary Outcomes (1)

  • Alteration of Brain Activities

    measured by magnetoencephalography

    At the time Immediately following the training

Secondary Outcomes (1)

  • The raw score change from baseline in the Movement disorder society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part Ⅲ scores

    At the time Immediately following the training

Study Arms (2)

Training with Neurofeedback

EXPERIMENTAL
Other: Training with Neurofeedback

The other Training with Neurofeedback

EXPERIMENTAL
Other: The other Training with Neurofeedback

Interventions

Neurofeedback the brain activities by Magnetoencephalography

Training with Neurofeedback

Neurofeedback the brain activities by Magnetoencephalography

The other Training with Neurofeedback

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with age more than 20
  • Subjects obtained the consent
  • Subjects with Parkinson disease and healthy subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka University

Suita, Osaka, 5650871, Japan

RECRUITING

Related Publications (1)

  • Izutsu N, Yanagisawa T, Fukuma R, Kishima H. Magnetoencephalographic neurofeedback training decreasesbeta-low-gammaphase-amplitude coupling of the motor cortex of healthy adults: a double-blinded randomized crossover feasibility study. J Neural Eng. 2023 May 9;20(3). doi: 10.1088/1741-2552/acd0d6.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2019

First Posted

February 12, 2019

Study Start

June 1, 2019

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

September 11, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations