Status:
NOT_YET_RECRUITING
Neurofeedback in Clinical High Risk
Lead Sponsor:
Boston VA Research Institute, Inc.
Conditions:
Real Neurofeedback From DMN
Sham Neurofeedback From Motor Cortex
Eligibility:
All Genders
12-30 years
Phase:
NA
Brief Summary
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...
Detailed Description
Identification of brain abnormalities in first episode schizophrenia (SZ) patients has provided evidence that disease-related abnormalities develop prior to psychosis and helped shift attention to the...
Eligibility Criteria
Inclusion
- For CHR Inclusion:
- 12-30 years old
- Native speaker or early learner (by age of 6) of English
- COPS diagnostic criteria met For HC Inclusion
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- 12-30 years old
- Native speaker or early learner (by age of 6) of English
- Provides a match with CHR subject on demographic matching variables
Exclusion
- For CHR:
- Exclusion:
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- 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
- Medication that interferes with assessment / presentation of psychosis risk or that could account for psychosis risk symptoms
- Antipsychotic medication administered in the absence of evidence the individual was still in the CHR state when treatment began
- Inability or refusal to provide informed consent
- For HC:
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- Meets criteria for a psychosis-risk syndrome
- Current or previous diagnosis for psychotic di sorder
- DSM-5 Cluster A personality disorder
- First degree biological relative with psychotic disorder or psychotic symptoms
- Current use of psychotropic medication
- WASI-II IQ \<70
- Congenital or acquired CNS disorder that interferes with cognition or produces psychosis risk-like symptoms
- Inability or refusal to provide informed consent
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06492343
Start Date
September 1 2024
End Date
December 1 2028
Last Update
July 9 2024
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