Actively Recruiting
Neural Biomarkers of Electroconvulsive Therapy Response
Led by Northwell Health · Updated on 2024-10-01
75
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neural Biomarkers of Electroconvulsive Therapy Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current positive symptoms rated moderate or higher on one or more BPRS 53 items: hallucinatory behavior, unusual thought content, suspiciousness, conceptual disorganization
- Has failed at least one trial of antipsychotic treatment lasting 6 weeks
- Competent and willing to sign informed consent
- For women, negative pregnancy test and agreement to use medically accepted birth control
- Diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder according to DSM-IV
You will not qualify if you...
- Serious neurological or endocrine disorder
- Any medical condition requiring treatment with psychotropic medication
- Significant risk of suicidal or homicidal behavior
- Cognitive impairment (MMSE 23 or less) or language limitations preventing informed consent
- Contraindications to electroconvulsive therapy
- Contraindications to MRI (e.g., pacemaker)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Actively Recruiting
Research Team
H
Heela Azizi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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