Neural Biomarkers of Electroconvulsive Therapy Response

  • STATUS
    Recruiting
  • End date
    Jul 1, 2024
  • participants needed
    75
  • sponsor
    Northwell Health
Updated on 7 March 2021

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.

Details
Condition Electroconvulsive Therapy Treated Patients
Treatment clinical and neuropsychological testing
Clinical Study IdentifierNCT04763655
SponsorNorthwell Health
Last Modified on7 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Electroconvulsive Therapy Treated Patients??
(1) current positive symptoms rated 4 (moderate) on one or more of these BPRS
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)
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