SchizophreniaNCT07659938
Frontal Gamma Coherence Neurofeedback for Patients With Schizophrenia
A study testing Frontal gamma coherence neurofeedback in people with Schizophrenia and Schizoaffective, run by BioSignal Solutions LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Schizoaffective
- What is being tested?
- Frontal gamma coherence neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2027to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
- Inability to read or speak English (with corrected vision or hearing if needed);
- Unable to adequately see or manually manipulate a smartphone, tablet or other mobile device;
Show all 9Show fewer
- Uncooperativeness with the laboratory assessment protocol leading to missing data;
- Color blindness that interferes with assessment;
- Testing in the past 6 months on the cognitive measures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California San Diego
La Jolla, California, 92093
Fiza Singh, MD, 858-267-2257, fnlab@health.ucsd.edu
About this study
Official title: Preliminary Placebo-Controlled Double-Blind Randomized Clinical Trial of Mobile Platform to Improve Memory From Home or Office for Patients With Schizophrenia
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective
- Being tested
- Frontal gamma coherence neurofeedback, Placebo Neurofeedback
- Keywords
- schizophrenia, working memory, gamma, EEG, neurofeedback, mobile, digital, neurotechnology
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frontal gamma coherence neurofeedbackDevice
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).
Placebo NeurofeedbackDevice
For participants randomized to Placebo-NFB, mobile treatment platform presents reinforcement signals recorded previously during active gcoh-NFB sessions from other participants
| Study group | Role | What they receive |
|---|---|---|
| Active frontal gamma coherence neurofeedback | Active comparator | Not described Receives: Device: Frontal gamma coherence neurofeedback |
| Placebo neurofeedback | Placebo comparator | Not described Receives: Device: Placebo Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 2-Back Accuracy During N-Back Testing From Baseline to Endpoint
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)
Measured: Baseline (Week 0) to Endpoint (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startApr 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSignal Solutions LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659938
- Sponsor's protocol ID
- BioSignal_2026_gcoh_NFB_0001
- Other IDs
- 1R43MH142174-01
- Status last verified
- Sep 2026
- First submitted
- 15 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be made publicly available. Because this SBIR-funded project involves translation of a proprietary EEG neurofeedback platform, the scientific data, device-use data, analytic outputs, and platform-related data are expected to include proprietary SBIR/STTR data. BioSignal Solutions LLC will preserve final research datasets and associated documentation internally to support NIH reporting, human-subjects oversight, regulatory development, intellectual-property protection, and scientific publications, as applicable. Aggregate findings may be disseminated through NIH reports, presentations, regulatory communications, and peer-reviewed publications. Any case-by-case sharing of data underlying a publication would be considered only if consistent with SBIR/STTR data rights, intellectual-property strategy, privacy protections, informed consent, IRB determinations, contractual obligations, applicable laws, and award terms.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Placebo-Controlled Double-Blind Randomized Clinical Trial of Mobile Platform to Improve Memory From Home or Office for Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07659938
- Acronym / sponsor ID
- BioSignal_2026_gcoh_NFB_0001
- Conditions
- Schizophrenia, Schizoaffective
- Keywords
- schizophrenia, working memory, gamma, EEG, neurofeedback, mobile, digital, neurotechnology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BioSignal Solutions LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of California, San Diego
- Study start
- Apr 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active frontal gamma coherence neurofeedback | Active comparator | Device: Frontal gamma coherence neurofeedback |
| Placebo neurofeedback | Placebo comparator | Device: Placebo Neurofeedback |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
- Inability to read or speak English (with corrected vision or hearing if needed);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frontal gamma coherence neurofeedbackFrontal 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). | Device | Active frontal gamma coherence neurofeedback |
| Placebo NeurofeedbackFor participants randomized to Placebo-NFB, mobile treatment platform presents reinforcement signals recorded previously during active gcoh-NFB sessions from other participants | Device | Placebo neurofeedback |
Primary outcome
Change in 2-Back Accuracy During N-Back Testing From Baseline to Endpoint
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. Because this SBIR-funded project involves translation of a proprietary EEG neurofeedback platform, the scientific data, device-use data, analytic outputs, and platform-related data are expected to include proprietary SBIR/STTR data. BioSignal Solutions LLC will preserve final research datasets and associated documentation internally to support NIH reporting, human-subjects oversight, regulatory development, intellectual-property protection, and scientific publications, as applicable. Aggregate findings may be disseminated through NIH reports, presentations, regulatory communications, and peer-reviewed publications. Any case-by-case sharing of data underlying a publication would be considered only if consistent with SBIR/STTR data rights, intellectual-property strategy, privacy protections, informed consent, IRB determinations, contractual obligations, applicable laws, and award terms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frontal gamma coherence neurofeedback in people with Schizophrenia and Schizoaffective, run by BioSignal Solutions LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiza Singh, MD (858-267-2257, fnlab@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 2-Back Accuracy During N-Back Testing From Baseline to Endpoint (time frame: Baseline (Week 0) to Endpoint (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.