Neural Biomarkers of Electroconvulsive Therapy Response
Study Details
Study Description
Brief Summary
In the proposed study, we 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 we will follow patients 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- Rate of Response [We will measure Brief Psychiatry Rating Scale weekly for 8 weeks.]
The outcome measure that we are interested in is the rate of change of the clinical response measured by the BPRS. To model the slope of change, we will use hierarchical linear modeling. Assuming linear improvement over time, the individual symptom trajectories may be modeled as Yij = β0j - β1j Xij + εij, where Y is the outcome measure (e.g. BPRS) at time i for patient j. β0j is the intercept and β1j is the slope for patient j, X.j is a vector of time predictor (in days from the start of the treatment), while ε is the error term (normally distributed with zero mean and unknown variance). In a second level analysis, we will extend to include sample averages of intercept and slope. In the second level analysis therefore we will estimate (1) β0j = μ0 + S0j and (2) β1j = μ1 + S1j, where S0j is the random intercept, and S1j is the random slope in patient j (the deviations from the group mean). The measure of primary interest in this study will be S1j.
Secondary Outcome Measures
- Cognitive change [Two time points: baseline and at 8th week.]
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) neuropsychology battery and its change.
- MRI of the brain [Two time points: baseline and at the end of the study]
Structural and functional MRI measures
- Electric field [At baseline.]
We will estimate first electrical field maps with finite element modeling from the structural scans.
Eligibility Criteria
Criteria
Inclusion Criteria:
(1) current positive symptoms rated ≥4 (moderate) on one or more of these BPRS 53 items: hallucinatory behavior, unusual thought content, suspiciousness, conceptual disorganization; (2) has failed at least one trial of treatment with antipsychotic drug, lasting 6 weeks in duration, (3) competent and willing to sign informed consent; (4) for women, negative pregnancy test and agreement to use a medically accepted birth control method; and (5) Diagnostic and Statistical Manual (DSM)-IV diagnosis of schizophrenia, schizoaffective or schizophreniform disorder.
Exclusion Criteria:
(1) serious neurological or endocrine disorder; (2) any medical condition which requires treatment with a medication with psychotropic effects; (3) significant risk of suicidal or homicidal behavior; (4) cognitive (MMSE ≤ 23) or language limitations that would preclude subjects providing informed consent; (5) contraindications to treatment with electroconvulsive therapy; (6) contraindications to magnetic resonance imaging (e.g. pacemaker)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Zucker Hillside Hospital | Glen Oaks | New York | United States | 11004 |
Sponsors and Collaborators
- Northwell Health
- National Institute of Mental Health (NIMH)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K23MH120504