Frontal Gamma Coherence Neurofeedback for Patients With Schizophrenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBioSignal Solutions LLC
About this trial
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.
Eligibility criteria
Qualifiers
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;
Age 18 to 55;
Meet DSM-5 criteria for a current diagnosis of schizophrenia or schizoaffective disorder based on a SCID-5 interview and available medical record review;
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
Disqualifiers
Electroconvulsive therapy within six months of the baseline assessment;
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;
Current (but not past) major depression;
Substance use disorder other than nicotine or caffeine in the past year;
Trial design
Treatments tested in this trial
- Frontal gamma coherence neurofeedback
- Placebo Neurofeedback
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
BioSignal Solutions LLC
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
University of California, San Diego
Collaborator
Source ClinicalTrials.gov