Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03049800 |
| Other study ID # |
PSYCH-2017-25501 |
| Secondary ID |
R21MH110208-01A1 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 12, 2017 |
| Est. completion date |
February 15, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
University of Minnesota |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
