Is Cognitive Training Neuroprotective in Early Psychosis?

February 15, 2021 updated by: University of Minnesota
The purpose of this study is to perform longitudinal high-resolution 7T MRI and Prisma 3T MRI in participants with first-episode psychosis (FEP) enrolled in our ongoing randomized controlled clinical trial (RCT) of cognitive training. The investigators seek to determine whether a 12-week course of intensive cognitive training of auditory processing in young FEP patients delivered remotely as a stand-alone treatment is neuroprotective against neural tissue loss in auditory cortex (superior temporal gyrus, STG), and possibly in other cortical regions. The investigators will also observe the effects of training on white matter integrity in the brain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The current protocol seeks to examine whether cognitive training can prevent accelerated gray matter loss and promote changes in the functional connectome in first-episode psychosis patients. Specifically, we aim to use Prisma 3T and 7T imaging to examine functional, structural, and diffusion weighted images to determine whether these treatments can influence neural plasticity. Scanning will be done at the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Participants will complete three approximately one-hour scanning sessions on the 3T Siemens Prisma scanner and three approximately one-hour scanning sessions on the 7T-AS scanner. We aim to use scan sequences compatible with the Human Connectome Project both for purposes of cross collaboration and data sharing.

This study will seek to enroll 80 participants. 60 participants will be considered First Episode Psychosis (FEP) patients, meaning that they have been diagnosed with a psychotic illness and have started receiving treatment at a First Episode Psychosis clinic (following the NAVIGATE model) within the last two years prior to enrollment. These participants will be recruited from a separate study protocol conducted by Dr. Sophia Vinogradov which examines remote cognitive training in FEP subjects (Minnesota Community-Based Cognitive Training in Early Psychosis, NCT03079024). 20 of these participants will receive treatment as usual (TAU), 20 will be assigned to Targeted Cognitive Training (TCT), and 20 will be assigned to Generalized Cognitive Exercises (GCE). Additionally, the investigators will enroll 20 healthy, age and gender matched controls (HC). All participants will undergo one 7T MRI and one Prisma scan at three time points: Baseline; Post-Intervention/12-weeks; and 6 month follow up.

The three 3T scan sessions will be matched as closely as possible, given hardware limitations, to the HCP 3T imaging protocol described here: http://protocols.humanconnectome.org/HCP/3T/imaging-protocols.html. This will include ~16 minutes of 3D structural imaging using MP-RAGE and T2-weighted scans, ~14 minutes of resting state fMRI relying on a gradient-echo EPI sequence, and 18 minutes of diffusion weighted MRI relying on a spin-echo EPI sequence. Scan parameters for acquisitions will seek to match the HCP Lifespan data acquired to date on the CMRR Prisma 3T.

For 7T scans, we will collect a standard T1-weighted MP2-RAGE structural scan, 12 minutes of resting fMRI using standard gradient-echo EPI sequences, and a diffusion-weighted DTI sequence compatible both with HCP and 7T-AS hardware. To maximize use of high-resolution imaging techniques while balancing ease of access and use, we aim to use the Siemens 7T-AS scanner with the NOVA 32-Channel head coil optimized for both structural and functional imaging.

Specific Aims

  1. Use the Siemens Prisma 3T MRI system and 7T MRIs to investigate longitudinal changes in brain gray matter volume in left Heschl gyrus (HG) and left planum temporale (PT) between baseline, post-training (approximately 12 weeks), and 12 months, within 20 FEP subjects who have undergone targeted cognitive training of auditory processing and 20 FEP subjects who have undergone general cognitive exercises, as compared to 20 treatment-as-usual FEP subjects and 20 age and gender matched healthy controls. Secondarily, we will also examine gray matter volume changes in prefrontal, parietal, and left hippocampual cortex.
  2. Use the Siemens Prisma 3T MRI system and 7T MRI to investigate longitudinal changes in left temporal lobe white matter integrity between baseline, post-training (approximately 12 weeks), and 12 months, within 20 FEP subjects who have undergone targeted cognitive training of auditory processing and 20 FEP subjects who have undergone general cognitive exercises, as compared to 20 treatment-as-usual FEP subjects and 20 age and gender matched healthy controls. Secondarily, we will also examine changes in left superior longitudinal fasiculus, left arcuate fasciculus, left uncinated fasciculus, left uncinated fasciculus, cingulum bundle, and corpus callosum.
  3. Investigate the association of changes in brain gray matter volume and white matter integrity with changes in clinical, cognitive and functional outcome measures in the FEP subjects who have undergone training.

Exploratory Aims

  1. Use Prisma 3T and 7T MRI to explore longitudinal changes between baseline, post-training (approximately 12 weeks), and at 6 month follow-up, in a novel putative MRI diffusion imaging biomarker that may represent neuroinflammation (extracellular volume fraction) in 20 FEP subjects who have undergone targeted cognitive training and 20 FEP subjects who have undergone general cognitive exercises, as compared to 20 treatment-as-usual FEP subjects and 20 age and gender matched healthy controls.
  2. Investigate the association of these changes with clinical, cognitive, and functional outcomes in the subject groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota, Dept of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

FEP participants will be currently enrolled in "Minnesota Community Based Cognitive Training in Early Schizophrenia," NCT03079024. This study examines cognitive training delivered remotely to patients who receive treatment for FEP at a NAVIGATE-model clinic. There are three groups in this study: one receives targeted cognitive training (TCT); one receives general cognitive exercises (GCE); and the third receives treatment-as-usual (TAU). Cognitive training groups complete up to 30 hours of training over 6-12 weeks. 20 participants in each arm will be recruited for a total of 60.

Control subjects who are matched to the FEP participants in age and gender will be recruited from the community. We will recruit a total of 20 psychologically and physically healthy adults for this study.

Description

First Episode Psychosis (FEP) Participants

Inclusion Criteria:

  • Enrolled in the Mini-COTES randomized controlled trial examining cognitive training in First Episode Psychosis (NCT03079024)
  • Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder, and started receiving treatment services at a First Episode Psychosis Program within the last two years
  • Good general physical health
  • Age between 16 and 35 (inclusive)
  • Fluent in written and spoken English
  • No neurological disorder (diagnosis of Autism Spectrum Disorder is allowed)
  • Achieved clinical stability, defined as outpatient status for at least one month prior to study participation, stable doses of psychiatric medications for at least one month prior to study participation
  • Women who are pregnant or breastfeeding may participate in this study

Healthy Controls (HC) Participants

Inclusion Criteria:

  • Age between 16 and 35 (inclusive)
  • Fluent in English
  • Good general physical health
  • No neurological disorder
  • No current or past diagnosis of a psychotic disorder, mood disorder, or anxiety disorder

All Participants

Exclusion Criteria:

  • Unable to provide informed consent (or assent if under 18)
  • Parents do not provide consent for participants under 18
  • Clinically significant substance abuse that is impeding the subject's ability to participate fully during recruitment, assessment, or training (is unable to remain sober for assessments).
  • Cannot pass the CMRR safety screen for receiving an MRI
  • Participant does not comply with study procedures. Exclusion is determined at PI discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
FEP - Treatment as Usual
First Episode Psychosis patients who receive treatment as usual while participating in an associated randomized controlled trial examining the effect of computerized cognitive training.
Device: Magnetic Resonance Imaging
Functional, structural, and diffusion weighted imaging conducted with a 7T-PS scanner and a Prisma 3T scanner.
FEP - Targeted Cognitive Training
First Episode Psychosis patients who receive targeted cognitive training exercises while participating in an associated randomized controlled trial examining the effect of computerized cognitive training.
Device: Magnetic Resonance Imaging
Functional, structural, and diffusion weighted imaging conducted with a 7T-PS scanner and a Prisma 3T scanner.
FEP - General Cognitive Exercises
First Episode Psychosis patients who receive general cognitive exercises while participating in an associated randomized controlled trial examining the effect of computerized cognitive training.
Device: Magnetic Resonance Imaging
Functional, structural, and diffusion weighted imaging conducted with a 7T-PS scanner and a Prisma 3T scanner.
Healthy Controls
Age and gender matched controls who are psychologically and physically healthy will be recruited from the community to participate in this cohort.
Device: Magnetic Resonance Imaging
Functional, structural, and diffusion weighted imaging conducted with a 7T-PS scanner and a Prisma 3T scanner.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Longitudinal changes in gray matter volume
Time Frame: 1 year
The investigators will conduct 3 7T and 3 Prisma 3T structural and functional MRI scans over a period of 10-12 months to observe any changes in gray matter volume between cohorts and over time. The investigators will examine gray matter volume in the left Heschl gyrus (HS), left planum temporale (PT), and the prefrontal, parietal, and hippocampal cortices.
1 year
Longitudinal changes in white matter integrity
Time Frame: 1 year
The investigators will conduct 3 7T and 3 Prisma 3T diffusion weighted MRI scans over a period of 10-12 months to observe any changes in white matter integrity between cohorts and over time. The investigators will examine changes in the left temporal lobe, left superior longitudinal fasiculus, left arcuate fasciculus, left uncinated fasciculus, left uncinated fasciculus, cingulum bundle, and corpus callosum.
1 year
Association of changes in gray matter volume and white matter integrity with changes in clinical, cognitive and functional outcome measures in FEP participants
Time Frame: 1 year
The investigators will compare the longitudinal changes in gray matter volume and in white matter integrity to the changes in measures of clinical, cognitive, and functional assessments in the associated randomized controlled study of cognitive training (NCT03079024), between cohorts and over time. The investigators will examine the differences between participants who received cognitive training and those who received treatment as usual.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Longitudinal changes in extracellular volume fraction
Time Frame: 1 year
The investigators will examine changes in MRI diffusion imaging of this novel biomarker that may represent neuroinflammation. The investigators will examine the changes between cohorts and over time.
1 year
Association between longitudinal changes in extracellular volume fraction and changes in clinical, cognitive, and functional outcomes in FEP participants.
Time Frame: 1 year
The investigators will compare the longitudinal changes in extracellular volume fraction to the changes in measures of clinical, cognitive, and functional assessments in the associated randomized controlled study of cognitive training (NCT03079024), between cohorts and over time. The investigators will examine the differences between participants who received cognitive training and those who received treatment as usual.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSYCH-2017-25501
  • R21MH110208-01A1 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from this study will be shared with the NIMH Data Archive, ID C2788. Additionally, interested collaborators may reach out to the PI directly to share data.

IPD Sharing Time Frame

Supporting information will be made available one year after completion of all study procedures, and will be available indefinitely.

IPD Sharing Access Criteria

Interested researchers may access this data using the NIMH Data Archive by following the requirements of this registry. Those who would like to see other supporting information may reach out to the PI directly. The PI may share data at their discretion, according to institutional policies, which may include entering into a Data Use Agreement and accessing data within a data shelter.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings