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Trial record 5 of 57 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Minnesota, United States ) | NIH, U.S. Fed

Is Cognitive Training Neuroprotective in Early Psychosis?

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ClinicalTrials.gov Identifier: NCT03049800
Recruitment Status : Recruiting
First Posted : February 10, 2017
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment
Psychosis Healthy Device: Magnetic Resonance Imaging

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Cognitive Training Neuroprotective in Early Psychosis?
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : June 12, 2020
Estimated Study Completion Date : June 12, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049800


Contacts
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Contact: Riley Capizzi 612-626-5167 minicotes@umn.edu
Contact: Brandon Schemitzler 612-626-0953 minicotes@umn.edu

Locations
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United States, Minnesota
University of Minnesota, Dept of Psychiatry Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Riley Capizzi    612-625-5167    minicotes@umn.edu   
Contact: Brandon Schermitzler    612-626-0953    minicotes@umn.edu   
Sub-Investigator: Melissa Fisher, Ph.D.         
Sub-Investigator: Ian Ramsay, Ph.D.         
Sub-Investigator: Bryon Mueller, Ph.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sophia Vinogradov, MD University of Minnesota Department of Psychiatry

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03049800     History of Changes
Other Study ID Numbers: 7T R21
R21MH110208-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Recent onset psychotic illness
Healthy controls
Cognitive training
7T Magnetic Resonance Imaging
Prisma 3T Magnetic Resonance Imaging

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders