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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 : June 27, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
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 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 Phase
Psychosis Healthy Device: Magnetic Resonance Imaging Behavioral: Treatment as Usual Behavioral: Targeted Cognitive Training Other: Healthy Controls Not Applicable

Detailed Description:
This study will seek to enroll 60 participants. 40 participants will be considered First Episode Psychosis (FEP) patients, meaning that they have been diagnosed with a psychotic illness with their first psychotic episode occurring within the last two years at time of enrollment. These participants will be recruited from a separate study protocol conducted by Dr. Sophia Vinogradov which examines remote cognitive training in FEP subjects (application in progress). 20 of these participants will receive treatment as usual (TAU), while 20 will be assigned to Targeted Cognitive Training (TCT). Additionally, the investigators will enroll 20 healthy, age and gender matched controls (HC). All participants will undergo 2 MRI scans approximately one year apart. Each MRI scan should last about one hour. The outcome measurements of this study will be changes in functional, structural, and diffusion weight images over time within subjects and between groups.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Active Comparator: Treatment as Usual
patients who receive treatment as usual while participating in a 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.

Behavioral: Treatment as Usual
patients who receive treatment as usual while participating in a randomized controlled trial examining the effect of computerized cognitive training.

Experimental: Targeted Cognitive Training
patients who receive targeted training while participating in a 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.

Behavioral: Targeted Cognitive Training
patients who receive targeted training while participating in a randomized controlled trial examining the effect of computerized cognitive training.

Placebo Comparator: 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.

Other: Healthy Controls
age and gender matched controls who are psychologically and physically healthy will be recruited from the community to participate in this cohort.




Primary Outcome Measures :
  1. Changes in Functional 7T MRI scans of the auditory cortex (superior temporal gyrus) [ Time Frame: 1 year ]
    The investigators will conduct 2 7T MRI scans over the course of one year to observe any changes in the functional, structural, and diffusion weight imaging between cohorts and over time. The investigators will be observing changes in neural tissue in the auditory cortex (superior temporal gyrus), and possibly in other related cortical regions.

  2. Changes in Structural 7T MRI scans of the auditory cortex (superior temporal gyrus) [ Time Frame: 1 year ]
    The investigators will conduct 2 7T MRI scans over the course of one year to observe any changes in the structural imaging between cohorts and over time. The investigators will be observing changes in neural tissue in the auditory cortex (superior temporal gyrus), and possibly in other related cortical regions.

  3. Changes in diffusion weight 7T MRI scans of the auditory cortex (superior temporal gyrus) [ Time Frame: 1 year ]
    The investigators will conduct 2 7T MRI scans over the course of one year to observe any changes in the diffusion weight imaging between cohorts and over time. The investigators will be observing changes in neural tissue in the auditory cortex (superior temporal gyrus), and possibly in other related cortical regions.

  4. Changes in white matter integrity [ Time Frame: 1 year ]
    The investigators will conduct 2 7T MRI scans over the course of one year to observe any changes in white matter integrity between cohorts and over time.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

First Episode Psychosis (FEP) Participants

Inclusion Criteria:

  • Enrolled in the Mini-COTES randomized controlled trial examining cognitive training in First Episode Psychosis
  • Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or unspecified schizophrenia spectrum disorder, with onset of first psychotic episode within the last 2 years.
  • Good general physical health
  • Age between 18 and 35 (inclusive)
  • Fluent in English
  • No substance dependence in the past 6 months determined by DSM-IV criteria
  • Achieved clinical stability, defined as outpatient status for at least 1 month prior to study participation plus stable doses of psychiatric medications for at least one month prior to study participation.

Exclusion Criteria:

  • Unable to provide informed consent
  • Cannot pass the CMRR safety screen for receiving an MRI

Healthy Controls (HC) Participants

Inclusion Criteria:

  • Age between 18 and 35 (inclusive)
  • Fluent in English
  • Good general physical health
  • No neurological disorder
  • No substance dependence in the past 6 months determined by DSM-IV criteria
  • No current or past diagnosis of a psychotic disorder, mood disorder, or anxiety disorder

Exclusion Criteria:

  • Unable to provide informed consent
  • Cannot pass the CMRR safety screen for receiving an MRI

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
Contact: Riley Capizzi 612-626-5167 minicotes@umn.edu
Contact: Shasteana Rancher 612-626-7886 minicotes@umn.edu

Locations
United States, Minnesota
University of Minnesota, Dept of Psychiatry Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Shasteana Rancher    612-625-7886    minicotes@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institutes of Health (NIH)
Investigators
Principal Investigator: Sophia Vinogradov, MD University of Minnesota Department of Psychiatry

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03049800     History of Changes
Other Study ID Numbers: 7T R21
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

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