Neurofeedback for Depression

Recruiting in Palo Alto (17 mi)

Overseen by Yvette I Sheline, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Must not be taking: Psychoactive medications

Disqualifiers: Pregnancy, Neurological disorder, Alcohol abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new therapy that uses brain scans to help patients with depression change their focus from negative to positive. It targets people with Major Depressive Disorder who often dwell on negative thoughts. The therapy provides real-time feedback and adjusts tasks to reduce negative focus.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any psychoactive medications, including antidepressants, to participate in this trial.

What data supports the effectiveness of the treatment Active Closed Loop Real Time fMRI Neurofeedback for depression?

Research shows that patients with depression who used real-time fMRI neurofeedback to regulate brain areas linked to positive emotions experienced significant improvements in their symptoms. However, more studies are needed to confirm these findings and rule out placebo effects. ^{1 2 3 4 5}

Is neurofeedback using real-time fMRI safe for humans?

Real-time fMRI neurofeedback has been used in studies with patients experiencing depression, showing promising results without reported safety concerns. However, more research is needed to confirm its safety and effectiveness across larger groups and different conditions. ^{1 2 3 6 7}

How does the treatment Active Closed Loop Real Time fMRI Neurofeedback differ from other treatments for depression?

This treatment is unique because it uses real-time brain imaging to help patients learn to regulate their own brain activity, specifically targeting areas involved in emotion processing. Unlike traditional therapies that rely on medication or talk therapy, this approach provides immediate feedback to patients, allowing them to practice achieving a healthier brain state during the sessions. ^{1 2 3 4 7}

Research Team

Yvette I Sheline, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

Adults aged 18-65 with Major Depressive Disorder (MDD) as per DSM-5, scoring at least 16 on the MADRS scale for depression severity. Participants must have normal cognition, understand English, and consent to join. Excluded are pregnant women, those outside the age range or with MRI contraindications like metal implants or claustrophobia, neurological issues affecting brain data or causing depression, recent substance abuse, non-correctable vision loss, active suicide risk or current psychoactive medication use.

Inclusion Criteria

I am between 18 and 65 years old and have been diagnosed with major depressive disorder.

Participants must be able to read and understand English

Scoring at least a minimum score of 16 on Montgomery Asberg Depression Rating Scale (MADRS)

Exclusion Criteria

I am currently taking medication for my mental health or am in therapy.

Pregnancy (female participants)

Refusal to provide informed consent

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Phase

Participants undergo four training sessions with either active or sham neurofeedback, each session lasting 32 minutes

4 sessions

R33 Phase

Number of training sessions are contingent on R61 findings, involving either active or sham neurofeedback

Contingent on R61 findings

Follow-up

Participants are monitored for changes in depression severity and attentional mechanisms

5 years

Treatment Details

Interventions

• Active Closed Loop Real Time fMRI Neurofeedback (Behavioral Intervention)
• Sham Closed Loop Real Time fMRI Neurofeedback (Behavioral Intervention)

Trial Overview The trial is testing a new therapy using real-time fMRI neurofeedback aimed at reducing negative attention bias in MDD patients. It involves decoding a patient's attentional state and adjusting task stimuli accordingly. The study compares actual neurofeedback against sham feedback to determine its effectiveness.

Participant Groups

Group I: Active Neurofeedback Active Control 1 Intervention

R61 Phase: Four training sessions. Each training session contains 32 minutes of active neurofeedback runs. R33 Phase: Number of training sessions are contingent on R61 findings.

Group II: Sham Neurofeedback Placebo Group 1 Intervention

R61 Phase: Four training sessions. Each training session contains 32 minutes of sham (placebo) neurofeedback runs. R33 Phase: Number of training sessions are contingent on R61 findings.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Center for Neuromodulation in Depression and Stress Philadelphia, PA

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2118

Patients Recruited

45,270,000+

Findings from Research

Real-time functional magnetic resonance imaging-based neurofeedback (rt-fMRI NF) is a promising technique for treating depression by training individuals to self-regulate brain areas like the amygdala, which is often overactive in response to negative stimuli.

Initial randomized controlled trials show promising results for rt-fMRI NF in improving emotional processing, but further research is needed to determine the best methods, target regions, and training durations for lasting clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Application of Real-Time fMRI-Based Neurofeedback for Depression. Mathiak, K., Keller, M.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Real-time self-regulation of emotion networks in patients with depression. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A real-time fMRI neurofeedback system for the clinical alleviation of depression with a subject-independent classification of brain states: A proof of principle study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Neurofeedback and networks of depression. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Individual- and Connectivity-Based Real-Time fMRI Neurofeedback to Modulate Emotion-Related Brain Responses in Patients with Depression: A Pilot Study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Time fMRI Neurofeedback Training as a Neurorehabilitation Approach on Depressive Disorders: A Systematic Review of Randomized Control Trials. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Connectivity based Real-Time fMRI Neurofeedback Training in Youth with a History of Major Depressive Disorder. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical Application of Real-Time fMRI-Based Neurofeedback for Depression. [2021]