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Frontal Gamma Coherence Neurofeedback for Patients With Schizophrenia

Preliminary Placebo-Controlled Double-Blind Randomized Clinical Trial of Mobile Platform to Improve Memory From Home or Office for Patients With 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

  • Time periods mentioned: 12 weeks

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
  • "Participants will complete baseline assessments in person at the University of California San Diego, receive training on home use of the neurofeedback platform, and complete twice-weekly 30-minute sessions at home for 12 weeks."
  • "All participants will be provided with mobile treatment platform, with instructions to practice gcoh-NFB from home twice weekly (30 minutes per session) for 12 weeks (24 sessions total)."
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 brain-wave feedback training in adults ages 18 to 55 with schizophrenia or schizoaffective disorder. It compares active training with placebo training to check how well people tolerate it and whether it affects thinking skills and brain activity. Participants use a study-provided mobile system at home twice a week for 12 weeks and attend visits at the University of California San Diego.

This preliminary, randomized, double-blind, placebo-controlled clinical trial will evaluate frontal gamma coherence neurofeedback in adults with schizophrenia. Thirty participants will be randomly assigned to receive either active neurofeedback or placebo neurofeedback using a study-provided mobile platform. Participants will complete baseline assessments in person at the University of California San Diego, receive training on home use of the neurofeedback platform, and complete twice-weekly 30-minute sessions at home for 12 weeks. Participants will return for midpoint and end-of-treatment assessments to evaluate feasibility, tolerability, cognitive outcomes, and neurophysiological target engagement.

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

Eligibility

Who can join

  • Can understand the study and freely agree to join, as checked by a short test.
  • Are 18 to 55 years old.
  • Have schizophrenia or schizoaffective disorder, which involves symptoms of schizophrenia and mood problems. The study team checks this through an interview and available medical records.
  • Have not stayed in a mental health hospital in the past 3 months.
  • Have had no dose changes to antipsychotic medicine in the 4 weeks before the first assessment.
  • A study doctor finds your mental and physical health stable.

Who can't join

  • Had electroconvulsive therapy, a treatment using electrical currents in the brain, in the past 6 months.
  • Have a health condition that can affect thinking, such as seizures, multiple sclerosis, stroke, major blood vessel disease, HIV/AIDS, brain cancer, or a past head injury that made you pass out.
  • Have major depression now, or had a substance use disorder in the past year other than nicotine or caffeine use disorder.
  • Cannot read or speak English, even with vision or hearing aids if needed.
  • Cannot see or use your hands well enough to operate a smartphone, tablet, or similar device.
  • Do not cooperate with study testing, causing missing test results.
  • Have color blindness that interferes with testing.
  • Took the same thinking-skills tests within the past 6 months.

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

Official eligibility criteria

Inclusion Criteria: 1. Voluntary informed consent to participate and capacity to consent as measured by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC1) instrument; 2. Age 18 to 55; 3. Meet DSM-5 criteria for a current diagnosis of schizophrenia or schizoaffective disorder based on a SCID-5 interview and available medical record review; 4. Clinically stable as operationalized by (a) not having been admitted to a psychiatric hospital within the three months prior to assessment, (b) having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and (c) ascertained to be clinically and medically stable by one of the study investigators Exclusion Criteria: 1. Electroconvulsive therapy within six months of the baseline assessment; 2. Medical conditions that can impact cognition, including self-reported history of seizure disorder; multiple sclerosis; stroke or major vascular disease; HIV/AIDS; brain cancer; prior head injury involving loss of consciousness; 3. Current (but not past) major depression; 4. Substance use disorder other than nicotine or caffeine in the past year; 5. Inability to read or speak English (with corrected vision or hearing if needed); 6. Unable to adequately see or manually manipulate a smartphone, tablet or other mobile device; 7. Uncooperativeness with the laboratory assessment protocol leading to missing data; 8. Color blindness that interferes with assessment; 9. Testing in the past 6 months on the cognitive measures

Study sites (1)

CA