Neural Biomarkers of Electroconvulsive Therapy Response

Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia

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.

Study Overview

• Status: Recruiting
• Conditions: Electroconvulsive Therapy Treated Patients
• Intervention / Treatment: Diagnostic test: clinical and neuropsychological testing

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heela Azizi; Phone Number: 718-470-8165; Email: hazizi1@northwell.edu

Study Locations

• United States
  • New York
    • Glen Oaks, New York, United States, 11004
      • Recruiting
      • The Zucker Hillside Hospital
      • Contact: Heela Azizi; Phone Number: 718-470-8165; Email: hazizi1@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Study Population

Schizophrenia spectrum disorder

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment as usual	Diagnostic test: clinical and neuropsychological testing; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 8 weeks.
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.	Baseline and 8 weeks.
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.	At baseline.

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Miklos Argyelan, MD, The Zucker Hillside Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18-0100; K23MH120504 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data is shared via the National Institute of Mental Health Data Archive mechanisms.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No