Prism Training for Depression

Recruiting at 1 trial location

Overseen By Adar Shani, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GrayMatters Health Ltd.

Must be taking: Antidepressants

Must not be taking: Fluoxetine, SSRIs, SNRIs, Bupropion

Disqualifiers: Suicidal behavior, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Prism for individuals with Major Depressive Disorder (MDD) who experience anhedonia, the loss of interest or pleasure in activities. Prism is a software used in clinics to provide neurofeedback training, which monitors brain activity through MRI and EEG. The trial includes two groups: one receiving real Prism training and another receiving a placebo version, to compare outcomes. Ideal participants are those diagnosed with MDD and anhedonia, who have tried at least one antidepressant without success. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options for MDD.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop your current medications, but you should not have started or changed certain antidepressants or psychiatric medications recently. If you have started or changed fluoxetine in the past 8 weeks or other similar medications in the past 4 weeks, you may not be eligible.

What prior data suggests that this software device is safe for use in neurofeedback training?

Research has shown that Prism training is a safe option for people with Major Depressive Disorder (MDD) who struggle to feel pleasure or interest in activities. Studies have found that this brain training, which uses MRI and EEG to monitor brain activity, is well-tolerated. Participants in these studies reported no serious side effects, indicating the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for depression, which often involve medications like SSRIs or psychotherapy, Prism training is unique because it uses reward system EEG-fMRI pattern (RS-EFP) Neuro Feedback (NF) to directly target brain activity. Researchers are excited about this method because it could offer a more personalized approach by harnessing real-time brain imaging and feedback to potentially enhance mood regulation. This technique is non-invasive and could provide an innovative alternative or complement to existing therapies, potentially offering faster and more precise results for individuals with depression.

What evidence suggests that the Prism software device is effective for Major Depressive Disorder?

Research has shown that Prism training, which uses a type of brain feedback, could help people with Major Depressive Disorder (MDD) who experience anhedonia, or difficulty feeling pleasure or interest. Studies have found that this method aids in managing brain activity linked to the reward system, which often malfunctions in depression. In this trial, participants in the active arm will receive reward system EEG-fMRI pattern (RS-EFP) Neuro Feedback (NF) Prism training. Earlier research participants who used the Prism device reported feeling better and more able to enjoy activities. This brain feedback method uses EEG and MRI to guide changes in brain activity and has shown promise in reducing symptoms. Overall, early findings suggest that Prism training might offer a new way to manage depression symptoms, especially for those dealing with anhedonia. ^{1 2 3 4 5}

Who Is on the Research Team?

Aron Tendler, MD

Principal Investigator

GrayMatters Health

Are You a Good Fit for This Trial?

This trial is for people with Major Depressive Disorder (MDD) who especially struggle to feel pleasure or interest in things, a condition known as anhedonia. Participants should be able to attend sessions in a clinic and undergo brain activity measurements like MRI and EEG.

Inclusion Criteria

Fluency in written and spoken English

Ability to give signed, informed consent either written or electronic (via REDCap eConsent)

Ability to adhere to the study schedule

Exclusion Criteria

Contraindications to MRI (e.g., metal in the body, claustrophobia)

Diagnosis for current moderate or severe substance or alcohol use disorder (SUD/AUD) within the past month (as defined in DSM-5-substance use disorder)

Any unstable medical condition, as per the clinical judgement of the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Initial assessment to establish baseline measures before treatment

1 week

1 visit (in-person)

Pre-training

Preparation and initial setup for neurofeedback training

1 week

1 visit (in-person)

Neurofeedback Training

Participants undergo 20 neurofeedback training sessions over 10 weeks

10 weeks

20 visits (in-person)

Booster Training

Additional neurofeedback training sessions to reinforce treatment effects

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prism

Trial Overview The study is testing Prism, a new software device designed for neurofeedback training aimed at treating MDD with anhedonia. It's used in a clinical setting where patients' brain activities are monitored and trained using advanced techniques.

How Is the Trial Designed?

Group I: Active arm Active Control 1 Intervention

Participants randomized into the Active arm will receive reward system EEG-fMRI pattern (RS-EFP) Neuro Feedback (NF) Prism training as an adjunct to SOC.

Group II: Sham arm Placebo Group 1 Intervention

Participants randomized into the Sham arm will receive a Sham EFP-NF training with the same schedule as the active arm, adjunct to SOC.

Who Is Running the Clinical Trial?

GrayMatters Health Ltd.

Lead Sponsor

Trials

4

Recruited

460+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12110136/

Reward System EEG–fMRI-Pattern Neurofeedback for ... This study aims to evaluate the safety and efficacy of a novel neurofeedback (NF) device (termed Prism) which incorporates the EEG–FRI-Pattern ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05869708

PRISM Neurofeedback Training for MDD Anhedonic ... The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123006613

Amygdala-derived-EEG-fMRI-pattern neurofeedback for ... A novel simultaneous EEG and fMRI recording technology (termed: Amygdala-derived- EEG-fMRI-Pattern [EFP) was used as part of a neurofeedback (NF) system.

4. researchgate.net researchgate.net/publication/391277887_Reward_System_EEG-fMRI-Pattern_Neurofeedback_for_Major_Depressive_Disorder_with_Anhedonia_A_Multicenter_Pilot_Study

(PDF) Reward System EEG–fMRI-Pattern Neurofeedback ... Conclusions: Self-neuromodulation using RS-EFP-NF is a promising and safe treatment for MDD with anhedonia. The intervention demonstrates ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40426646/

Reward System EEG-fMRI-Pattern Neurofeedback for ... This study aims to evaluate the safety and efficacy of a novel neurofeedback (NF) device (termed Prism) which incorporates the EEG-FRI-Pattern biomarker of the ...