RecruitingPhase 1Phase 2NCT06557525

Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)


Sponsor

UNB Sumiyoshi Jinja Mae Clinic

Enrollment

30 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called FRONTIER) is testing a brain-training technique called neurofeedback — where you can see real-time information about your own brain activity and learn to regulate it — as a treatment for depression in people who have not fully recovered with antidepressants alone. **You may be eligible if...** - You are 18 or older and have been diagnosed with major depressive disorder - Your depression is at least moderate severity (based on standardized rating scales) - You are currently taking antidepressants and willing to continue them during the study, OR you are not currently on antidepressants - You are being treated by a psychiatrist - You can have MRI scans (no metal implants, no claustrophobia) **You may NOT be eligible if...** - You have active suicidal thoughts or a history of suicide attempts - You have been hospitalized for depression - You have a history of seizures, epilepsy, or significant brain disease - You have a drug or alcohol addiction - You are pregnant or not willing to use contraception - You are participating in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNeurofeedback

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.


Locations(1)

UNB Sumiyoshi Jinja Mae Clinic

Fukuoka, Japan

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NCT06557525


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