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Not yet recruitingNCT07788755Updated Nov 3, 2026

NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia

An interventional study of Perceptual Discrimination Training and Cognitive Control Training in Schizophrenia, Schizoaffective Disorder and Cognitive Impairment, sponsored by University of Minnesota. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by University of Minnesota · Not applicable, Interventional, and Basic science

Updated Nov 3, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
  • Cognitive Impairment
  • Visual Impairment

Keywords

  • NEURO-COGS
  • Schizophrenia
  • Cognitive training
  • Schizoaffective disorder
  • BrainHQ
  • Perceptual discrimination training
  • Brain metabolism
03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 168 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

All participants (healthy control and SZ):

  • Age: 18-79
  • Have given written
  • 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
  • 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 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

Exclusion Criteria:

Exclusion criteria for both groups are:

  • Presence of major neurological disorder
  • Conditions preventing MR scanning or other MRI :

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.

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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
168 participants (estimated)

Study arms

  • Experimental
    Perceptual Discrimination Training

    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.

    Device: Perceptual Discrimination Training

  • Experimental
    Cognitive Control Training

    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.

    Device: Cognitive Control Training

Interventions

  • DevicePerceptual 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.

    Also known as: BrainHQ Perceptual Discrimination Training

  • DeviceCognitive 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.

    Also known as: BrainHQ Cognitive Control Training

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

  2. 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

    Time frame: 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

  3. 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

    Time frame: 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

  1. 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.

    Time frame: 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

  2. 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.

    Time frame: 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

  3. 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.

    Time frame: 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

  4. 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.

    Time frame: 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

  5. 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.

    Time frame: 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

07

Study locations

1 site
  • Center for Magnetic Resonance Research, University of Minnesota
    Minneapolis, Minnesota 55455, United States
    • Caroline Demro, PhD, LP · Contactschi0599@umn.edu · 612-625-3330
    • Caroline Demro, PhD, LP · Principal investigator
08

Updates

2 registry updates since Sep 25, 2026
Start date
Oct 1, 2026→Nov 16, 2026
moved 2 times, Oct 2, 2026 – Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    Start date Nov 2, 2026→Nov 16, 2026
    + 1 other change: verification date
  2. Oct 2, 2026
    Start date Oct 1, 2026→Nov 2, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07788755
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Nov 16, 2026 (estimated)
Primary completion
Jun 1, 2031 (estimated)
Completion
Jun 1, 2031 (estimated)
Last update
Nov 3, 2026

Study contacts

Caroline Demro, PhD, LP
Contact
schi0599@umn.edu
612-625-3330
Claire McDonald
Contact
mcdo1202@umn.edu
Caroline Demro, PhD, LP
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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