Suspended

Use of Electroconvulsive Therapy to Treat Self-Injurious Behavior in Adults With Autism Spectrum Disorders

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What is being tested

Electroconvulsive Therapy (ECT)

Device
Who is being recruted

Autism Spectrum Disorder+4

+ Behavior

+ Mental Disorders

From 18 to 89 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2019
See protocol details

Summary

Principal SponsorEastern Virginia Medical School
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 15, 2019

Actual date on which the first participant was enrolled.

Potential participants will be screened for inclusion/exclusion criteria. They must have a confirmed ASD diagnosis and be generally healthy. As part of the inclusion and exclusion criteria, the participant must have an appointment with their primary care provider or a hospital internist to complete a physical exam and required tests (EKG, CXR \[chest x-ray\], CMP \[Comprehensive Metabolic Profile\], CBC \[Complete Blood Count\], and head CTscan). At the first pre-treatment appointment (Visit 1), the participant and their legal guardian will review and sign the consent and assent forms with the investigator. The legal guardian also sign a Sentara Norfolk General Hospital release of medical information. The guardian will then fill out the ASD Diagnostic Checklist, Repetitive Behavior Scale- Revised, and the Aberrant Behavior Checklist. The physician will complete the Self-Injury Trauma Scale, which documents the number, type, and severity of unhealed self-injury traumas. At the end of the Visit 1, the guardian will receive a Subject Diary Card to record the number of self-injury episodes per day, the number of aggressive episodes per day, and the perceived severity of episodes that day. The Diary Card also has space to record the medication taken by the participant every day. The second pre-treatment appointment (Visit 2) will consist of a complete psychiatric evaluation with review of all medical evaluations. The subject must receive medical clearance to undergo ECT treatment. The first Diary Card will be collected at this time, and a second Diary Card will be given. After receiving medical clearance, participants (accompanied by their guardians) will begin to receive ECT treatments. They will receive ECT 3 times a week for 4 weeks, for a total of 12 treatments (Visits 3- 14). All ECT treatments will take place in the Outpatient Surgery and Diagnostic Unit of Sentara Norfolk General Hospital, and will be performed by Dr. Shriti Patel or Dr. Justin Petri. All subjects will receive bilateral ECT. Participants will be placed under general anesthesia (Etomidate) and given a primary muscle relaxant (Succinylcholine). An anesthesiologist or nurse anesthetist will be present and will hyperventilate the patient to lower their seizure threshold. The first ECT treatment (Visit 3) will determine the participant's seizure threshold. Subsequent ECT treatments (Visits 4-14) will be determined by the acting psychiatrist based on the patient's seizure threshold. Following the procedure, the patient will recover in the Post Anesthesia Care Unit. Throughout the course of the treatment, guardians will continue filling out the Diary Card. Once treatment begins, guardians will be asked to also include any side effects of the treatment noted by themselves or the participant. Guardians will turn in and receive new Diary Cards weekly. After acute ECT treatment is complete, patients and their guardians will return to Eastern Virginia Medical School (EVMS) Department of Psychiatry and Behavioral Sciences for post-treatment appointments (Visits 15-18). At these post-treatment appointment guardians will complete the ASD Diagnostic Checklist, Repetitive Behavior Scale- Revised, and the Aberrant Behavior Checklist. The psychiatrist will complete a second Self-Injury Trauma Scale. At this time the Diary Card will be collected and subjects will receive Diary Cards for 1 month. Visits 15-18 will occur at 1 month, 2 months, 6 months, and 12 months post - acute ECT treatment.

Official TitleUse of Electroconvulsive Therapy to Treat Self-Injurious Behavior in Adults With Autism Spectrum Disorders
Principal SponsorEastern Virginia Medical School
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1 patient to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autism Spectrum DisorderBehaviorMental DisordersBehavioral SymptomsChild Development Disorders, PervasiveSelf-Injurious BehaviorNeurodevelopmental Disorders

Criteria

Inclusion Criteria: Participants must have: * a documented Autism Spectrum Disorder diagnosis * a present history of self-injurious behavior for which they have tried and failed at least four other treatment methods * a legal guardian who is able to consent to medical treatments and attend all appointments with the participant. * Subjects will obtain an EKG, Chest X-Ray, Complete Metabolic Panel, Complete Blood Count, and a head CT to receive medical clearance prior to participating in the ECT. Exclusion Criteria: Participants will be excluded if they are: * under the age of 18 * older than age of 89 * do not have a present history of self-injury * have tried fewer than four other treatment methods for self-injurious behavior * if following their pre-treatment tests, they have medical conditions that would present them with undue risk for undergoing ECT.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
After initial exams and pre-screening, participants will receive bilateral Electroconvulsive Therapy (ECT) for 12 treatments sessions over the course of 4 weeks, plus non-ECT follow-up sessions at 1, 2, 6, and 12 months post-ECT treatment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Eastern Virginia Medical School

Norfolk, United StatesOpen Eastern Virginia Medical School in Google Maps
SuspendedOne Study Center