Decoded Neurofeedback for Schizophrenia

(DecNef Trial)

Not yet recruiting at 2 trial locations
KM
Overseen ByKatelyn Mills
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
Must be taking: Antipsychotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether specialized neurofeedback training during MRI scans can reduce hallucinations, such as hearing voices, in people with schizophrenia. The treatment, called Decoded Neurofeedback, uses real-time brain pattern feedback to alter brain activity related to these symptoms. The trial includes two groups: one receiving neurofeedback targeting schizophrenia symptoms and a control group not specifically targeting these symptoms. Individuals with schizophrenia or schizoaffective disorder who experience frequent auditory hallucinations despite treatment and are on a stable dose of antipsychotic medication may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new ways of managing schizophrenia symptoms.

What prior data suggests that this neurofeedback technique is safe for schizophrenia patients?

Research has shown that neurofeedback, a technique to help control brain activity, is generally safe for treating schizophrenia. Studies have found it can lessen symptoms like hallucinations and delusions without causing serious side effects. Most people tolerate it well, experiencing no major issues during treatment. While researchers continue to study neurofeedback, the evidence so far supports its safety in managing schizophrenia symptoms.12345

Why are researchers excited about this trial?

Most treatments for schizophrenia, like antipsychotic medications, aim to manage symptoms by altering chemical signals in the brain. But Decoded Neurofeedback offers a fresh approach by using a real-time fMRI technique to modulate brain activity directly through pattern-based neurofeedback. This method targets specific brain activation patterns, potentially inducing selective brain plasticity. Researchers are excited because this could lead to more personalized and precise symptom management, potentially reducing side effects associated with traditional medications.

What evidence suggests that this neurofeedback technique is effective for schizophrenia?

Research has shown that neurofeedback, including a type called Decoded Neurofeedback, may help treat schizophrenia. In one study, 47 out of 48 participants improved after using neurofeedback, as indicated by their PANSS scores, which measure symptom severity. Another study found that combining neurofeedback with medication reduced both positive symptoms (like hallucinations) and negative symptoms (such as lack of motivation). In this trial, participants will receive either Active Decoded Neurofeedback, which targets brain activity patterns to potentially reduce hallucinations, or a Control condition that does not target schizophrenia symptoms. Overall, neurofeedback has proven effective for many symptoms, showing significant progress in treating schizophrenia.12346

Who Is on the Research Team?

GH

Guillermo Horga, MD, PhD

Principal Investigator

Columbia University

JK

Joshua Kantrowitz, MD

Principal Investigator

Columbia University / New York State Psychiatric Institute

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with schizophrenia or schizoaffective disorder who continue to hear voices (auditory hallucinations) even after standard treatments. Participants must be able to undergo MRI scans and follow study instructions.

Inclusion Criteria

I understand the study and can give my consent to participate.
I am between 18 and 55 years old.
Mean Auditory Hallucination Rating Scale (AHRS) score >2 (moderate) and AHRS Frequency ≥ 4 (hourly AVH: Frequent at least 3 to 6 per hour)
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Exclusion Criteria

Diagnosis of moderate or severe substance use disorder (excluding nicotine) within the previous 90 days
Pregnant persons; persons of child-bearing potential must have a negative urine β-hCG pregnancy test at Visit 1 and Visit 1a (if applicable)
Any clinically significant or unstable medical illness, condition, or disorder anticipated to potentially compromise participant safety during study, including history of seizure, epilepsy in self or first degree relatives, stroke, brain surgery, head injury with loss of consciousness > 1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesions
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo decoded neurofeedback training during MRI scans to modulate brain activation patterns

8-12 weeks
Weekly MRI sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment using the Auditory Hallucination Rating Scale

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Decoded Neurofeedback

Trial Overview

The study tests a new type of neurofeedback training, called Decoded Neurofeedback, given during MRI scans. The goal is to see if this approach can help reduce persistent auditory hallucinations in people with schizophrenia-related conditions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Active Decoded NeurofeedbackExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

New York State Psychiatric Institute

Collaborator

Trials
481
Recruited
154,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Neurofeedback Treatment of Negative Symptoms in ... - PMC

These findings suggest that neurofeedback poses a promising treatment of negative symptoms in schizophrenia and should be examined in more detail with respect ...

Systematic review and meta-analysis of the effects of EEG ...

The results of this study indicate that EEG-NF therapy, in combination with medication, improved both positive and negative symptoms in schizophrenia patients, ...

NCT07779226 | DecNef for AVH in Schizophrenia

The purpose of this study is to learn whether a research neurofeedback training approach done during MRI scans may help reduce hallucinations such as the ...

Systematic Review of the Potential Use of Neurofeedback in ...

As a treatment protocol, NF has been used successfully to address a variety of neuropsychiatric disorders, including attention-deficit hyperactivity disorder ( ...

Neurofeedback for Schizophrenia · Info for Participants

One study found that 47 out of 48 participants improved after receiving neurofeedback, as reflected in their PANSS scores, a tool used to measure the severity ...

Neurofeedback and Schizophrenia

Neurofeedback training has been shown to be safe and effective for many symptoms, including hallucinations, and we have seen substantial progress per the Case ...