Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

NCT ID: NCT06557525

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2025-03-31

Brief Summary

This is an exploratory study to test the efficacy of a novel EEG neurofeedback method in depressed patients. The investigators will measure the change in depressive symptoms before and after the intervention of the novel EEG neurofeedback method using the Depression Rating Scale (primary endpoint). In addition, The investigators will measure the changes in brain activity before and after the intervention using fMRI, and compare the changes in depressive symptoms over the treatment period (secondary endpoint).

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neurofeedback

Group Type: EXPERIMENTAL

Neurofeedback

Intervention Type: BEHAVIORAL

Subjects will receive neurofeedback training by visual stimulation using a software program on a PC or tablet (monitor) with reference to EEG data acquired with a portable electroencephalograph (EEG) to provide feedback on the state of the DLPFC in the brain. The DLPFC status of the subject's brain is then fed back to the subject to continue stimulating the subject's reward system. Before and after these neurofeedback training sessions, fMRI imaging will be performed to confirm changes in brain activity.

Interventions

Neurofeedback

Subjects will receive neurofeedback training by visual stimulation using a software program on a PC or tablet (monitor) with reference to EEG data acquired with a portable electroencephalograph (EEG) to provide feedback on the state of the DLPFC in the brain. The DLPFC status of the subject's brain is then fed back to the subject to continue stimulating the subject's reward system. Before and after these neurofeedback training sessions, fMRI imaging will be performed to confirm changes in brain activity.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 1. Adults (at least 18 years old at the time consent is obtained)
• 2. Major depressive episode as defined by the diagnostic criteria of the DSM 5
• 3. One of the following

1. Hamilton Depression Rating Score (HDRS 17) of 19 or higher

2. Montgomery Asberg Depression Rating Scale score of 20 or higher

3. Any other patient deemed appropriate by the PI (subprincipal investigator)

• 4. With respect to taking antidepressants, any of the following

1. not taking antidepressants

2. If taking antidepressants, willingness to continue them for the duration of the program.

• 5. If receiving psychotherapy, agree to continue the same psychotherapy for the duration of study participation
• 6. Have treated by a psychiatrist
• 7. Written informed consent
• 8. No planned change in employment status after the study begins

Exclusion Criteria

• 1. High risk of suicide, such as suicidal ideation or suicide attempts
• 2. History of hospitalization for depression or suicidal behavior
• 3. Comorbid addictions (drugs, alcohol) or history of addictions
• 4. Organic brain disease (e.g., moderate or severe intracranial organic lesions or neurodegenerative disease)
• 5. History of seizures or epilepsy
• 6. Has a serious or unstable physical disease
• 7. Difficulty or inappropriateness/contraindication to MRI imaging
• 8. Pregnant women or unwilling to practice contraception during the study
• 9. Participating in another clinical trial at the same time, or have participated in a clinical trial within the past 90 days, or are scheduled to participate in another clinical trial during the study period, and the principal (sub)investigator determines that participation in another clinical trial may interfere with the results of this study
• 10. Other cases in which the principal investigator (or subinvestigator) determines that it is difficult to conduct this study safely.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universal Brain, LLC

UNKNOWN

Sponsor Role: collaborator

UNB Sumiyoshi Jinja Mae Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UNB Sumiyoshi Jinja Mae Clinic

Fukuoka, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Hiroaki Harashima

Role: CONTACT

study@unbclinic.com

092-477-1101

Facility Contacts

Hiroaki Harashima

Role: primary

study@unbclinic.com

092-477-1101

Other Identifiers

frontier

Identifier Type: -

Identifier Source: org_study_id