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NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia

2026年8月24日 更新者:University of Minnesota

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

168

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Caroline Demro, PhD, LP
  • 電話番号:612-625-3330
  • メール:schi0599@umn.edu

研究連絡先のバックアップ

研究場所

    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55455
        • Center for Magnetic Resonance Research, University of Minnesota
        • コンタクト:
          • Caroline Demro, PhD, LP
          • 電話番号:612-625-3330
          • メール:schi0599@umn.edu
        • 主任研究者:
          • Caroline Demro, PhD, LP

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
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.
他の名前:
  • BrainHQ Perceptual Discrimination Training
実験的: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.
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.
他の名前:
  • BrainHQ Cognitive Control Training

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in DPX Task Performance
時間枠: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
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
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
時間枠: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

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

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
時間枠: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

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

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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Brief Psychiatric Rating Scale Score
時間枠: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
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.
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
時間枠: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
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.
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
時間枠: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
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.
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
時間枠: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
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.
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
時間枠: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
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.
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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Caroline Demro, PhD, LP、University of Minnesota

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2031年6月1日

研究の完了 (推定)

2031年6月1日

試験登録日

最初に提出

2026年7月31日

QC基準を満たした最初の提出物

2026年8月24日

最初の投稿 (実際)

2026年8月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月26日

QC基準を満たした最後の更新が送信されました

2026年8月24日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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