Neural Biomarkers of Electroconvulsive Therapy Response
- Conditions
- Electroconvulsive Therapy Treated Patients
- Interventions
- Diagnostic Test: clinical and neuropsychological testing
- Registration Number
- NCT04763655
- Lead Sponsor
- Northwell Health
- Brief Summary
In the proposed study, the investigators will utilize resting-state functional MRI (fMRI) and structural MRI-based electrical field modeling to study the effect of electroconvulsive therapy on human neural circuitry. Our study will recruit patients who are beginning treatment with bilateral electroconvulsive therapy (N=75). Our design will be longitudinal where patients will be followed up until their 8th week electroconvulsive therapy clinically. The primary measure of interest will be the slope of clinical change estimated with mixed effect modeling (see Approach). Secondary measures will be the cognitive performance change between baseline and the 8th week electroconvulsive therapy time point.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- current positive symptoms rated ≥4 (moderate) on one or more of these BPRS 53 items: hallucinatory behavior, unusual thought content, suspiciousness, conceptual disorganization;
- has failed at least one trial of treatment with antipsychotic drug, lasting 6 weeks in duration,
- competent and willing to sign informed consent;
- for women, negative pregnancy test and agreement to use a medically accepted birth control method; and
- Diagnostic and Statistical Manual (DSM)-IV diagnosis of schizophrenia, schizoaffective or schizophreniform disorder.
- serious neurological or endocrine disorder;
- any medical condition which requires treatment with a medication with psychotropic effects;
- significant risk of suicidal or homicidal behavior;
- cognitive (MMSE ≤ 23) or language limitations that would preclude subjects providing informed consent;
- contraindications to treatment with electroconvulsive therapy;
- contraindications to magnetic resonance imaging (e.g. pacemaker)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment as usual clinical and neuropsychological testing -
- Primary Outcome Measures
Name Time Method Rate of Response to Brief Psychiatry Rating Scale (BPRS) Baseline and 8 weeks. The change of total BPRS score between Week 8 and Baseline divided by baseline (percentage change). The change in the total score which can be between 18-126 (in extreme cases) will be reported.
- Secondary Outcome Measures
Name Time Method The change of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Baseline and 8 weeks. Using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) neuropsychology battery, the age corrected standardized total T-scores change will be reported.
Volume change of the hippocampus bilaterally based on MRI based volumetry Baseline and 8 weeks. Volume change in the hippocampus measured by subtracting the volume of the bilateral hippocampus at 8th week from baseline divided by baseline (percentage). A longitudinal FreeSurfer (MGH) will be used to measure the volumes of the hippocampus in cubic centimeters and the change will be reported.
Magnitude of the electric field in the hippocampus bilaterally At baseline. The electrical field will be estimated with finite element modeling from the structural scans in the hippocampus (Volt per meter). A Matlab based program called ROAST (developed at CUNY) to estimate the electric field in the hippocampus and the average electric field magnitude across the hippocampus will be reported.
Trial Locations
- Locations (1)
The Zucker Hillside Hospital
🇺🇸Glen Oaks, New York, United States