Cerebellar-Prefrontal Network Connectivity and Negative Symptoms in Schizophrenia.
Roscoe O Brady, Irene Gonsalvez, Ivy Lee...
https://pubmed.ncbi.nlm.nih.gov/30696271Actively Recruiting
Phase Not Applicable
Age: 15Years - 35Years
All Genders
Healthy Volunteers
ID06542640
Identifying Mechanisms of Response to Therapeutic Intervention in Clinical High Risk (CHR) for Psychosis: a Bridge to Treatment
Led by Beth Israel Deaconess Medical Center · Updated on 2025-04-20
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
S
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying individuals at clinical high risk (CHR) for psychosis to understand how different biomarkers relate to the development of psychosis and other clinical outcomes. This study builds on previous findings to explore novel biomarkers and brain circuit targets that may predict and influence the course of early psychosis. The goal is to identify how the brain's ability to change (neural plasticity) affects outcomes and to pave the way for future treatment options. Participants will be randomly assigned to one of five groups: two groups receive real interventions using either repetitive transcranial magnetic stimulation (rTMS) targeting a specific brain circuit related to symptoms or mindfulness-based real-time functional MRI neurofeedback (mb-rt-fMRI-NFB) aimed at the frontal lobe. Two other groups receive similar sham (placebo) interventions targeted to unrelated brain areas. A healthy control group will not receive treatment but will be monitored for comparison. These interventions are delivered non-invasively and aim to engage brain networks involved in psychosis symptoms. During the study, participants undergo assessments at 1 month, 1 year, and 2 years to measure changes in brain function using functional connectivity via MRI, as well as clinical evaluations and various neuropsychological tests covering learning, memory, attention, and problem solving. Additional measurements include event-related potentials, natural language processing, structural MRI, and diffusion tensor imaging. The study will follow participants over five years to monitor outcomes and the impact of the interventions on biomarker abnormalities and clinical symptoms.
CONDITIONS
Brief Title
Mechanisms of Response to Therapeutic Intervention in Clinical High Risk (CHR) for Psychosis
Who Can Participate
Age: 15Years - 35Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Male or female between 15 and 35 years old
- Able to understand and sign informed consent or assent
- No alcohol or drug dependence in the past 3 months
- No substance use on the day of assessment and not intoxicated or hung-over
- Meet diagnostic criteria for a prodromal syndrome or Schizotypal Personality Disorder under age 19
- May be remitted from CHR syndrome or have converted to full psychotic disorder but still eligible for follow-up
You will not qualify if you...
- Current or past Axis I psychotic disorder, including affective psychoses and psychosis not otherwise specified
- Intellectual functioning with IQ below 70
- Significant central nervous system disorder affecting prodromal symptoms
- Severe traumatic brain injury or current concussion interfering with assessments
- Prodromal symptoms clearly caused by other psychiatric disorders or substance use disorders
- For healthy controls: must not have any prodromal syndrome, psychotic disorder, or Cluster A personality disorder, and no psychotropic medication use
- Healthy controls must have no family history of schizophrenia, schizoaffective disorder, schizotypal personality disorder, or psychotic disorders in first-degree relatives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Not specified
Participants receive one of the four interventions: mindfulness-based real time fMRI neurofeedback (mb-rt-fMRI-NFB), sham mb-rt-fMRI-NFB, repetitive transcranial magnetic stimulation (rTMS), or sham rTMS, targeting specific brain regions or networks related to psychosis symptoms.
Multiple intervention sessions as part of the device-based treatment
Long-term Monitoring
Duration - Up to 2 years
Participants are monitored for clinical, neuropsychological, electrophysiological, and neuroimaging outcomes over time to assess intervention effects and brain function changes.
Follow-up visits at 1 month, 1 year, and 2 years after intervention
Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Loading map...
Research Team
W
William S Stone, Ph.D.
M
Margaret A Niznikiewicz, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Real-time fMRI feedback impacts brain activation, results in auditory hallucinations reduction: Part 1: Superior temporal gyrus -Preliminary evidence.
Kana Okano, Clemens C C Bauer, Satrajit S Ghosh...
https://pubmed.ncbi.nlm.nih.gov/32113035Real-time fMRI neurofeedback reduces auditory hallucinations and modulates resting state connectivity of involved brain regions: Part 2: Default mode network -preliminary evidence.
Clemens C C Bauer, Kana Okano, Satrajit S Ghosh...
https://pubmed.ncbi.nlm.nih.gov/32004893Dynamic intervention-based biomarkers may reduce heterogeneity and motivate targeted interventions in clinical high risk for psychosis.
M A Niznikiewicz, R O Brady, S Whitfield-Gabrieli...
https://pubmed.ncbi.nlm.nih.gov/35709648