Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

NCT06557525 | Recruiting Phase 1 DMC

• 1 other identifier: frontier
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• HAMD21 change after intervention

  HAMD21(Hamilton Depression Rating Scale, 21-item version) score change compared to baseline.

  4 weeks after the start of the intervention

Secondary Outcomes (11)

• HAMD21 compared to baseline

  2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention

• MADRS compared to baseline

  2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention

• SDS compared to baseline

  2 and 4 weeks after the start of the intervention and 4, 12, and 24 weeks after the end of the intervention

• HAMD21 after intervention

  4 weeks after the start of the intervention

• MADRS after intervention

  4 weeks after the start of the intervention

Study Arms (1)

Neurofeedback

EXPERIMENTAL

Behavioral: Neurofeedback

Interventions

Neurofeedback 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.

Neurofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adults (at least 18 years old at the time consent is obtained)
• \. Major depressive episode as defined by the diagnostic criteria of the DSM 5
• \. One of the following
• Hamilton Depression Rating Score (HDRS 17) of 19 or higher
• Montgomery Asberg Depression Rating Scale score of 20 or higher
• Any other patient deemed appropriate by the PI (subprincipal investigator)
• \. With respect to taking antidepressants, any of the following
• not taking antidepressants
• If taking antidepressants, willingness to continue them for the duration of the program.
• \. If receiving psychotherapy, agree to continue the same psychotherapy for the duration of study participation
• \. Have treated by a psychiatrist
• \. Written informed consent
• \. No planned change in employment status after the study begins

You may not qualify if:

• \. High risk of suicide, such as suicidal ideation or suicide attempts
• \. History of hospitalization for depression or suicidal behavior
• \. Comorbid addictions (drugs, alcohol) or history of addictions
• \. Organic brain disease (e.g., moderate or severe intracranial organic lesions or neurodegenerative disease)
• \. History of seizures or epilepsy
• \. Has a serious or unstable physical disease
• \. Difficulty or inappropriateness/contraindication to MRI imaging
• \. Pregnant women or unwilling to practice contraception during the study
• \. 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
• \. Other cases in which the principal investigator (or subinvestigator) determines that it is difficult to conduct this study safely.

Sponsors & Collaborators

• UNB Sumiyoshi Jinja Mae Clinic: lead
• Universal Brain, LLC: collaborator

Study Sites (1)

UNB Sumiyoshi Jinja Mae Clinic

Fukuoka, 812-0018, Japan

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

Hiroaki Harashima

CONTACT

092-477-1101; study@unbclinic.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: August 16, 2024
• Study Start: November 20, 2023
• Primary Completion: September 30, 2024
• Study Completion: March 31, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

JP (1)