NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Presence of major neurological disorder
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Perceptual Discrimination Training
DevicePerceptual 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 Training
DeviceCognitive 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.
Treatment groups
168 Participants
are divided into 2 treatment groupsGroup A: Perceptual Discrimination TrainingExperimental treatment 1 intervention
Group B: Cognitive Control TrainingExperimental treatment 1 intervention
Trial outcomes
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 component2
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 component3
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 componentSecondary 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 component2
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 component3
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 component4
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 componentSponsors and contacts
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Source ClinicalTrials.gov
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