Is Cognitive Training Neuroprotective in Early Psychosis?

NCT03049800 | Completed FDA Device

• 2 other identifiers: PSYCH-2017-25501R21MH110208-01A1
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychosis; Healthy

Keywords

Recent onset psychotic illness; Healthy controls; Cognitive training; 7T Magnetic Resonance Imaging; Prisma 3T Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (3)

• Longitudinal changes in gray matter volume

  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

  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

  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 Outcomes (2)

• Longitudinal changes in extracellular volume fraction

  1 year

• Association between longitudinal changes in extracellular volume fraction and changes in clinical, cognitive, and functional outcomes in FEP participants.

  1 year

Study Arms (4)

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

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

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

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

Interventions

Magnetic Resonance Imaging DEVICE

Functional, structural, and diffusion weighted imaging conducted with a 7T-PS scanner and a Prisma 3T scanner.

FEP - General Cognitive Exercises; FEP - Targeted Cognitive Training; FEP - Treatment as Usual; Healthy Controls

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota, Dept of Psychiatry

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sophia Vinogradov, MD

  University of Minnesota Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 10, 2017
• Study Start: June 12, 2017
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Supporting information will be made available one year after completion of all study procedures, and will be available indefinitely.
• 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.

Locations

US (1)