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Decoded Neurofeedback for Schizophrenia

(DecNef Trial)

Not yet recruiting at 1 trial location
KM
Overseen ByKatelyn Mills
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: New York State Psychiatric Institute
Must be taking: Antipsychotics
Disqualifiers: Substance use disorder, Pregnancy, Seizure, others
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?

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 experience of hearing voices persistent despite treatment.

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?

New York State Psychiatric Institute

Lead Sponsor

Trials
481
Recruited
154,000+

Columbia University

Collaborator

Trials
1,529
Recruited
2,832,000+

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