Neurofeedback in Clinical High Risk
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-30
SponsorBoston VA Research Institute, Inc.
About this trial
The goal of this trial is to test whether fMRI based neurofeedback from default mode network (DMN) will reduce DMN hyperconnectivity in clinical high risk individuals, which will lead to reductions in clinical symptoms and improve cognitive performance.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
12-30 years old
Native speaker or early learner (by age of 6) of English
COPS diagnostic criteria met For HC Inclusion
12-30 years old
Disqualifiers
Meeting DSM-5 criteria for lifetime psychotic disorder, including affective psychoses
WASI-II IQ < 70
Psychosis risk symptoms caused by other psychiatric disorders (including substance use/misuse)
Congenital or acquired CNS disorder that could account for psychosis-risk or cognitive symptoms
Trial design
Design model
Parallel
Treatments tested in this trial
fMRI based neurofeedback
Other interventionparticipants will receive neurofeedback from their brain in order to modify their own brain function
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: real NFB from DMNExperimental treatment 1 intervention
Group B: sham NFB from motor cortexExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
rs-FMRI DMN changes, post-NFB
reductions in resting state functional connectivity MPFC-PPC in real NFB group only
Time frame
three weeks2
rs fMRI MPFC-STG changes, post-NFB
reductions in MPFC-PCC resting state functional connectivity, post NFB, in real NFB group only
Time frame
three weeksSecondary outcomes
1
GABA in MPFC
GABA levels at baseline in MPFC
Time frame
one weekLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: