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NCT Number: NCT04763655

Neural Biomarkers of Electroconvulsive Therapy Response

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.

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Key information

Conditions

Electroconvulsive Therapy Treated Patients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location status: Recruiting

Location contact

Heela Azizi

CONTACT

[email protected]

718-470-8165

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

clinical and neuropsychological testing

Diagnostic Test

Patients 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

Other names: MRI of the brain

Primary outcomes

  1. Rate of Response to Brief Psychiatry Rating Scale (BPRS)

    Time frame: 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 outcomes

  1. The change of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)

    Time frame: 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.

  2. Volume change of the hippocampus bilaterally based on MRI based volumetry

    Time frame: 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.

  3. Magnitude of the electric field in the hippocampus bilaterally

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heela Azizi

CONTACT

[email protected]

718-470-8165

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Feb 21, 2021
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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