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NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia

NEUROmetabolic Mechanisms of COGnitive Training in Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 79 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will complete behavioral assessments, cognitive testing, electroencephalography, magnetic resonance imaging, and magnetic resonance spectroscopy assessments."
  • "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 completing cognitive training, participants will return for follow-up assessments, including repeat clinical assessments, cognitive and visual tasks, EEG, MRI, and magnetic resonance spectroscopy."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how two computer-based thinking training programs affect thinking, vision, and brain activity and chemicals. It is for adults ages 18–79 with schizophrenia or schizoaffective disorder and healthy adults. Participants are assigned by chance to a program and complete about 10 hours of training over 2–6 weeks, plus tests and brain scans.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–79 years old, give written consent, and be able to read and write in English.
  • Live in a Minnesota county about a one-hour drive from the Twin Cities.
  • Be in good general physical health, with no major brain or nerve disorder or head injury that caused a long period of unconsciousness.
  • Agree not to use recreational drugs, including marijuana, for one week before each scan.
  • For the schizophrenia group: have schizophrenia or schizoaffective disorder, which can affect thoughts, sense of reality, and mood.
  • For the schizophrenia group: have no suicide attempt or hospital stay for mental health care in the past month.
  • For the schizophrenia group: have received care outside a hospital and taken stable doses of mental health medicines for at least one month.
  • For the schizophrenia group: meet the study's limits on how severe symptoms are and how much they have worsened.

Who can't join

  • A major brain or nerve disorder, epilepsy, a developmental disability, vision problems, or another health condition that makes the study unsuitable.
  • An implanted device, metal object in the body, or another condition that prevents a safe MRI scan; pregnancy or breastfeeding.
  • A movement disorder that could disrupt brain scans, such as uncontrolled movements caused by tardive dyskinesia.
  • An estimated IQ below 70.
  • A current moderate or severe substance use disorder, meaning problems caused by alcohol or drug use. Caffeine and nicotine do not count.
  • For healthy adults: a personal or immediate family history of the listed mental health disorders, including psychosis, bipolar disorder, depression, PTSD, panic disorder, or obsessive-compulsive disorder.
  • For healthy adults: a close or second-degree relative, such as a grandparent, with schizophrenia, another psychotic disorder, or bipolar I or II disorder.
  • For healthy adults: current symptoms of the listed disorders involving mood, loss of touch with reality, panic, trauma, unwanted thoughts or repeated actions, alcohol or drug use, or suicide risk.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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 * 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 Exclusion Criteria: Exclusion criteria for both groups are: * 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. 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

Study sites (1)

MN