Schizoaffective, Schizophrenia
Conditions
Keywords
schizophrenia, working memory, gamma, EEG, neurofeedback, mobile, digital, neurotechnology
Brief summary
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.
Detailed description
In this preliminary placebo-controlled, double-blind randomized clinical trial (RCT), eligible participants will be randomized (block permutation) to either Active frontal coherence gamma neurofeedback (gcoh-NFB, n = 15) or Placebo neurofeedback (placebo-NFB, n = 15). All participants will present in person to Univ. of Ca. San Diego (UCSD) for Baseline assessments of primary and secondary outcome measures, and will receive training on self-administration of gcoh-NFB from home. 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). Study personnel will reach out to patient by phone and video at least weekly to facilitate gcoh-NFB self administration. Staff will be available by phone and video more frequently, as indicated by participant performance or preference. All participants will return to UCSD for midpoint (Week 6, or after 12 sessions) and end-of-treatment (Week 12, or after 24 session) in person assessments of primary and secondary outcome measures, and maintenance or return of mobile treatment platform. For participants randomized to Active gcoh-NFB, mobile treatment platform presents reinforcement signals coupled in real time to target neurobiological features. For participants randomized to Placebo-NFB, mobile treatment platform presents reinforcement signals recorded previously during active gcoh-NFB sessions from other participants.
Interventions
BEHAVIORALFrontal gamma coherence neurofeedback
Frontal gamma coherence neurofeedback (gcoh-NFB) uses electroencephalographic (EEG) to reward active maintenance of gamma coherence recorded at frontal F3 and F4 electrode sites (from the International 10-20 System for EEG electrode placement).
BEHAVIORALPlacebo Neurofeedback
For participants randomized to Placebo-NFB, mobile treatment platform presents reinforcement signals recorded previously during active gcoh-NFB sessions from other participants
Sponsors
BioSignal Solutions LLC
National Institute of Mental Health (NIMH)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 2-Back Accuracy During N-Back Testing From Baseline to Endpoint | Baseline (Week 0) to Endpoint (Week 12) | Total accuracy, across target and nontarget trials, for the 2-Back condition, during N-Back testing (calculated as percent of responses correct; lowest possible accuracy, 0; highest possible accuracy, 100; higher accuracy corresponds to higher working memory performance) |
Countries
United States
Contacts
CONTACTFiza Singh, MD
Outcome results
None listed