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DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia

Decoded fMRI Neurofeedback for Auditory Verbal Hallucinations in Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether brain feedback training during MRI scans may help reduce hearing voices that continue despite treatment. It is for adults ages 18 to 55 with schizophrenia or schizoaffective disorder.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 55 years old at screening.
  • Understand the study and be willing and able to agree to take part.
  • Have schizophrenia or schizoaffective disorder.
  • Take an antipsychotic medicine at the same dose for at least 4 weeks. Pills and long-acting shots are allowed.
  • Have a hearing-voices symptom score above 2 on the study scale, with voices occurring at least 3 to 6 times per hour.
  • Have a brain-scan decoding test score of at least 55% accuracy. Study doctors may allow one repeat scan if the score is too low.
  • Be able to hear normal conversation.
  • If able to become pregnant, agree to use study-approved birth control throughout the study.

Who can't join

  • Have had a moderate or severe substance use disorder in the past 90 days, not counting nicotine.
  • Test positive for drugs of abuse.
  • Have joined a study of an experimental medicine or device in the past 4 weeks.
  • Be pregnant. Those able to become pregnant must have a negative urine pregnancy test at Visit 1 and Visit 1a, if needed.
  • Have a serious or unstable health problem that may make the study unsafe. Examples include seizures; epilepsy in you or a parent, sibling, or child; stroke; brain surgery; a head injury causing over 1 hour of unconsciousness or lasting thinking problems; metal in the skull; or known brain damage.
  • Be unable to safely have an MRI, such as because of metal implants or a strong fear of small spaces.
  • Have had suicidal thoughts with intent or a plan in the past 3 months, or be judged at serious risk of suicide or violence.
  • Have had serious violent behavior in the past 3 months, pose a risk of killing someone, or have symptoms that study visits or travel could make worse.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Individuals aged 18 to 55, inclusive at screen * Capable of understanding the study procedures and willing and able to provide informed consent * Diagnosed with schizophrenia or schizoaffective disorder * Taking an antipsychotic medication at a stable dose for at least 4 weeks. All oral and depot antipsychotics are allowable. * Mean Auditory Hallucination Rating Scale (AHRS) score \>2 (moderate) and AHRS Frequency ≥ 4 (hourly AVH: Frequent at least 3 to 6 per hour). * Meeting the decoder performance criterion, operationalized as ≥ 55% decoding accuracy. Baseline MRI may be repeated once for subthreshold decoder-accuracy at the discretion of the PIs. * Normal hearing, operationalized as normal conversational hearing. * Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for persons of childbearing potential only, unless post-menopausal or surgically sterile). Exclusion Criteria: * Diagnosis of moderate or severe substance use disorder (excluding nicotine) within the previous 90 days * Positive toxicology screen for any substances of abuse * Participation in study of investigational medication/device within the past 4 weeks * 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 that is 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. * Contraindication to MRI scanning, including metal implants or clinically meaningful claustrophobia * Participants with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 3 months prior to screening or participants who represent a significant risk of suicide or violence in the opinion of the investigator. * History of significant violent behavior in the past 3 months, posing a risk of homicide or having symptoms that would be exacerbated by study participation or travel to the site in the opinion of the investigator.

Study sites (2)

NY