RECRUITING

Neural Biomarkers of Electroconvulsive Therapy Response

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia

Quick Facts

Study Start:2020-04-01
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04763655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. has failed at least one trial of treatment with antipsychotic drug, lasting 6 weeks in duration,
  3. 3. competent and willing to sign informed consent;
  4. 4. for women, negative pregnancy test and agreement to use a medically accepted birth control method; and
  5. 5. Diagnostic and Statistical Manual (DSM)-IV diagnosis of schizophrenia, schizoaffective or schizophreniform disorder.
  1. 1. serious neurological or endocrine disorder;
  2. 2. any medical condition which requires treatment with a medication with psychotropic effects;
  3. 3. significant risk of suicidal or homicidal behavior;
  4. 4. cognitive (MMSE ≤ 23) or language limitations that would preclude subjects providing informed consent;
  5. 5. contraindications to treatment with electroconvulsive therapy;
  6. 6. contraindications to magnetic resonance imaging (e.g. pacemaker)

Contacts and Locations

Study Contact

Heela Azizi
CONTACT
718-470-8165
hazizi1@northwell.edu

Principal Investigator

Miklos Argyelan, MD
PRINCIPAL_INVESTIGATOR
The Zucker Hillside Hospital

Study Locations (Sites)

The Zucker Hillside Hospital
Glen Oaks, New York, 11004
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • Miklos Argyelan, MD, PRINCIPAL_INVESTIGATOR, The Zucker Hillside Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-01
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2020-04-01
Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Electroconvulsive Therapy Treated Patients