SchizophreniaNCT07788755
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
A study testing Perceptual Discrimination Training in people with Schizophrenia and Schizoaffective Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
This study will examine brain metabolic and excitatory/inhibitory mechanisms related to cognitive and visual functioning in adults with schizophrenia and healthy control participants. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Cognitive Impairment
- What is being tested?
- Perceptual Discrimination Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2026to 1 Jun 2031
- Phase
- Interventional
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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants (healthy control and SZ):
- Age: 18-79
- Have given written informed consent
- Be able to read and write in English
- General health status: Participants should be in good general physical health (no major neurological disorder or head injury with prolonged unconsciousness, and no current moderate or severe substance use disorder)
- Geographic location: Minnesota counties that are approximately within 1 hour driving distance to Twin Cities, including, but not limited to, Hennepin, Ramsey, Washington, Anoka, Wright, Carver, Scott, Dakota, Sherburn
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- Agree to refrain from using recreational drugs for 1 week prior to each scanning session, including, but not limited to, marijuana
- For people with schizophrenia (SZ):
- Current DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Participants should be in stable psychiatric health, evidenced by no suicide attempt or psychiatric hospitalization within the past 1 month. (Initial diagnosis will be assessed using SCID 5 or MINI-7, and confirmation of ongoing SZ status and symptom changes will be monitored at each major timepoint using BPRS.)
- All SZ must have achieved clinical stability, defined as outpatient status for at least one month prior to study participation, plus stable doses of psychiatric medications for at least 1 month prior to study participation (as reported by participants and confirmed via medication list (procured by participants via their own medical or pharmacy records) and/or current pill bottle labels).
- All participants should have symptom ratings below a rating of 7 "extremely severe" on a severity scale of 1-7 on the BPRS and/or below grade 3 on longitudinal assessment defined by (as determined by the PI):
- Grade 1: Worsening of 1 point on any item within each BPRS factor
- Grade 2: Worsening of 2 points on any item within each BPRS factor
- Grade 3: Worsening of 3+ points on any item within each BPRS factor, or a change to a rating of extremely severe
- Grade 4: Suicide attempt with intent to die
Who cannot join
- Presence of major neurological disorder
- Conditions preventing MR scanning or other MRI contraindications:
- Implanted devices or ferromagnetic objects, current pregnancy (positive pregnancy test on day of MRI scanning or currently breast-feeding), etc. Significant movement disorders including tardive dyskinesia that could disrupt MRI and MRS recordings. Medically significant condition considered unsuitable for the current study (e.g., epilepsy, etc.)
- Estimated IQ < 70
- Other relevant comorbidity (e.g., epilepsy, developmental disability) or visual impairment
- Presence of current substance use disorder (moderate or severe; excluding caffeine and nicotine), as measured by the MINI-7 or SCID 5 based on DSM-5 criteria.
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- For healthy controls, additionally:
- Personal or immediate first-degree family history of a psychotic or mood disorder. Specifically, current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, or Bipolar I or II Disorder, major depressive disorder, posttraumatic stress disorder, panic disorder, obsessive compulsive disorder, dysthymic disorder. Those with a first or second-degree relative with a current or past history of meeting DSM-5 criteria for schizophrenia or other psychotic disorders or bipolar I or II disorder, because they might have an underlying genetic susceptibility for psychosis symptoms.
- Presence of symptoms of the following DSM-5 disorders (as assessed by the MINI-7 or SCID 5):
- Major Depressive Episode
- Suicidality
- Manic and Hypomanic Episodes
- Panic disorder
- Obsessive-Compulsive Disorder
- Posttraumatic Stress Disorder
- Alcohol Use Disorder
- Substance Use Disorder (Non-Alcoholic)
- Psychotic Disorders and Mood Disorders with Psychotic Features
- Medication or substance induced psychosis
- Major Depressive Disorder (MDD)
- MDD with Psychotic Features
- Bipolar I
- Bipolar II
- Other Specified Bipolar and Related Disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Claire McDonald contact
United States1 site
Center for Magnetic Resonance Research, University of Minnesota
Minneapolis, Minnesota, 55455
Caroline Demro, PhD, LP, 612-625-3330, schi0599@umn.edu
Caroline Demro, PhD, LP
About this study
Official title: NEUROmetabolic Mechanisms of COGnitive Training in Schizophrenia
This study will examine brain metabolic and excitatory/inhibitory mechanisms related to cognitive and visual functioning in adults with schizophrenia and healthy control participants.
Participants will complete behavioral assessments, cognitive testing, electroencephalography, magnetic resonance imaging, and magnetic resonance spectroscopy assessments. After baseline assessments, participants will be randomly assigned to one of two computerized cognitive training programs: perceptual discrimination training or cognitive control training. Each training program will include approximately 10 hours of training over 2 to 6 weeks.
The study will evaluate changes in cognitive and visual task performance, EEG measures, and brain metabolite concentrations before and after cognitive training. Some participants may also complete optional extended baseline assessments before cognitive training.
Read the detailed description
Schizophrenia is associated with cognitive and visual impairments that can persist across the lifespan and are not fully addressed by current antipsychotic treatments. These impairments may be related to disruptions in brain metabolism and excitatory/inhibitory balance. This study is designed to better understand neurochemical and neurophysiological mechanisms of cognitive and visual functioning in schizophrenia and to evaluate whether these mechanisms change following cognitive training.
The study will enroll adults with schizophrenia or schizoaffective disorder and demographically similar healthy control participants. Participants will complete baseline clinical assessments, cognitive and visual tasks, electroencephalography, structural magnetic resonance imaging, and magnetic resonance spectroscopy. Magnetic resonance spectroscopy will be used to measure brain metabolite concentrations, including metabolites related to brain metabolism and excitatory/inhibitory function.
After baseline assessments, participants will be randomly assigned to one of two computerized cognitive training programs: perceptual discrimination training or cognitive control training. Both training programs are delivered through the BrainHQ platform and include approximately 10 hours of training over a 2- to 6-week period. Perceptual discrimination training focuses on visual stimulus discrimination, signal-to-noise resolution, and attentional control. Cognitive control training focuses on maintaining cognitive context in working memory during response selection.
After completing cognitive training, participants will return for follow-up assessments, including repeat clinical assessments, cognitive and visual tasks, EEG, MRI, and magnetic resonance spectroscopy. Participants may also choose to complete an optional extended baseline component with additional baseline scanning visits before cognitive training.
The primary outcomes include behavioral performance on the DPX task variant, EEG variables related to excitatory/inhibitory balance, and magnetic resonance spectroscopy measures of neurometabolite concentrations. Secondary outcomes include symptom and functioning measures such as the Brief Psychiatric Rating Scale, Scale for the Assessment of Negative Symptoms, Scale for the Assessment of Positive Symptoms, World Health Organization Disability Assessment Schedule, and Global Functioning Social/Role scales.
- Being tested
- Perceptual Discrimination Training, Cognitive Control Training
- Keywords
- NEURO-COGS, Schizophrenia, Cognitive training, Schizoaffective disorder, BrainHQ, Perceptual discrimination training, Brain metabolism
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Cognitive Dysfunction, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptual Discrimination TrainingDevice
Also called BrainHQ Perceptual Discrimination Training
Perceptual discrimination training is a computerized cognitive training program delivered through the BrainHQ platform. Training involves Gabor patch and other visual stimulus discrimination exercises that focus on improving signal-to-noise resolution and attentional control. On each training trial, participants distinguish a target stimulus among distractor stimuli. Training difficulty adapts based on participant performance. Participants complete approximately 10 hours of training over 2 to 6 weeks.
Cognitive Control TrainingDevice
Also called BrainHQ Cognitive Control Training
Cognitive control training is a computerized cognitive training program delivered through the BrainHQ platform. Training involves maintaining accurate representations of cognitive context in working memory during response selection. Training difficulty adapts based on participant performance by changing the speed of stimulus presentation or working memory load. Participants complete approximately 10 hours of training over 2 to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Perceptual Discrimination Training | Experimental | Participants randomized to this arm will complete computerized perceptual discrimination training. The training involves Gabor patch and other visual stimulus discrimination exercises designed to improve signal-to-noise resolution and attentional control. Participants will complete approximately 10 hours of training over 2 to 6 weeks. Receives: Device: Perceptual Discrimination Training |
| Cognitive Control Training | Experimental | Participants randomized to this arm will complete computerized cognitive control training. The training involves exercises focused on maintaining cognitive context in working memory during response selection. Participants will complete approximately 10 hours of training over 2 to 6 weeks. Receives: Device: Cognitive Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DPX Task Performance
Behavioral performance on the DPX task variant will be assessed as a measure of cognitive control. Trial-by-trial behavioral data will be used to derive observed behavioral and computational metrics of cognitive control. The DPX task variant consists of a series of pattern sequences. One pattern is designated the "A" cue followed by the "X" cue, which requires one response (AX, 60-70% of trials, e.g. respond with the left button), while other pattern sequences require a different response (AY or BX, 12-15% of trials each, or BY, 6-10% of trials, e.g. respond with the right button). Given the strong expectation that X's evoke a valid response, BX trials place demands on cognitive control via the fidelity (stability, memory) of the "B" cue representation to overcome this tendency. Unit of Measure: Mean and standard deviation for BX trial error rate
Measured: Baseline to post-training follow-up, up to 7 months; or baseline to post-training follow-up, up to 42 months for participants completing the optional extended baseline component
Number of participants with pre/post EEG data
The final sample size (participants with resting electroencephalography before and after intervention) will be reported to facilitate future analyses of change in EEG variables, which could include phase synchrony, slope of the spectral power density indexing excitatory/inhibitory balance, and/or prefrontal/parietal theta as a measure of perceptual noise.
Units of Measure: Number of participants with pre/post EEG data
Measured: Baseline to post-training follow-up, up to 7 months; or baseline to post-training follow-up, up to 42 months for participants completing the optional extended baseline component
Number of participants with pre/post Magnetic Resonance Spectroscopy data
Magnetic resonance spectroscopy (MRS) will be used to measure neurometabolite concentrations, including but not limited to glutamate, GABA, glutathione, and glucose. MRS measurements will be collected from prefrontal and occipital cortex. The final sample size (participants with MRS before and after intervention) will be reported to facilitate future analyses of change in MRS variables.
Units of Measure: Number of participants with pre/post MRS data
Measured: Baseline to post-training follow-up, up to 7 months; or baseline to post-training follow-up, up to 42 months for participants completing the optional extended baseline component
Secondary outcomes (5)
Change in Brief Psychiatric Rating Scale Score
Psychiatric symptoms will be assessed using the Brief Psychiatric Rating Scale.Brief Psychiatric Rating Scale (BPRS) items are scored between 1-7 with higher scores meaning more severe symptoms (i.e., worse outcomes). The minimum score is 24, and the maximum score is 168.
Measured: Baseline to post-training follow-up, up to 7 months; or baseline to post-training follow-up, up to 42 months for participants completing the optional extended baseline component
Change in Positive Symptom Scores
Positive symptoms will be assessed using the Scale for the Assessment of Positive Symptoms(SAPS). Items are scored from 0 to 5, with higher scores indicating more severe symptoms and a worse outcome. Total scores range from 0 to 170.
Measured: Baseline to post-training follow-up, up to 7 months; or baseline to post-training follow-up, up to 42 months for participants completing the optional extended baseline component
Change in Negative Symptom Scores
Negative symptoms will be assessed using the Scale for the Assessment of Negative Symptoms(SANS). Items are scored from 0 to 5, with higher scores indicating more severe symptoms and a worse outcome. Total scores range from 0 to 125.
Measured: Baseline to post-training follow-up, up to 7 months; or baseline to post-training follow-up, up to 42 months for participants completing the optional extended baseline component
Change in World Health Organization Disability Assessment Schedule Score
Functioning will be assessed using the World Health Organization Disability Assessment Schedule, which assesses domains including cognition, mobility, self-care, social interaction, and social and participatory activities. The World Health Organization Disability Assessment Schedule (WHODAS) is scored so that higher values indicate more severe impacts of disability (i.e., a worse outcome). Each item is scored between 0-4 with a minimum score of zero and a maximum score of 48.
Measured: Baseline to post-training follow-up, up to 7 months; or baseline to post-training follow-up, up to 42 months for participants completing the optional extended baseline component
Change in Global Functioning Role Scale Score
Real-world role functioning in work or school will be assessed using the Global Functioning Role Scale. This scale is rated from 1 to 10, with higher scores indicating better role functioning. A score of 10 represents superior functioning.
Measured: Baseline to post-training follow-up, up to 7 months; or baseline to post-training follow-up, up to 42 months for participants completing the optional extended baseline component
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start2 Nov 2026 (estimated)
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Jun 2031 (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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two computerized cognitive training interventions: perceptual discrimination training or cognitive control training. Both training programs include approximately 10 hours of training delivered over a 2- to 6-week period.
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Demro, PhD, LP, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788755
- Sponsor's protocol ID
- PSYCH-2026-34877
- Other IDs
- 34877
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes