Neural Biomarkers of Electroconvulsive Therapy Response
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNorthwell Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
clinical and neuropsychological testing
Diagnostic testPatients are monitored with Brief Psychiatric Rating Scale (BPRS) weekly and structural and functional MRI and MATRICS battery before and at the end of the course of the study
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Treatment as usualOther 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Response to Brief Psychiatry Rating Scale (BPRS)
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.
Time frame
Baseline and 8 weeks.Secondary outcomes
1
The change of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
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.
Time frame
Baseline and 8 weeks.2
Volume change of the hippocampus bilaterally based on MRI based volumetry
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.
Time frame
Baseline and 8 weeks.3
Magnitude of the electric field in the hippocampus bilaterally
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.
Time frame
At baseline.Sponsors and contacts
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Northwell Health
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov