Clinical trial NCT03980366: Use of Electroconvulsive Therapy to Treat Self-Injurious Behavior in Adults With Autism Spectrum Disorders
Official title: Use of Electroconvulsive Therapy to Treat Self-Injurious Behavior in Adults With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism Spectrum Disorder
Self-Injurious Behavior
Keywords: Electroconvulsive Therapy
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: Sentara Norfolk General Hospital
First posted: 2019-06-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects and their legally-appointed guardians will participate in a total of 18 visits over the course of 1 year. Visits 1 and 2 will occur during weeks 1 and 2. These visits will be for psychiatric and medical evaluations and will take about 1 hour each. Visits 3-14 will take place three times a week for four weeks. These visits will be for the ECT treatments and will take about 2-3 hours each. Visit 15 will take place 1 week post-treatment and visit 16 will take place 4 weeks post-treatment. Guardians will keep a daily diary card between visits 1 and 16, spanning a time of 10 weeks. Visits 17 and 18 will take place at 6 months and 12 months, respectively, and take about 1 hour each.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to use formal measures to monitor the outcome of using electroconvulsive therapy to treat self-injurious behavior in adults with Autism Spectrum Disorder for whom psychotropic medication has not worked. This study will be fundamentally different from the previously published literature on the subject in that this will be a prospective study which will aim to recruit multiple participants in an open label study.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Changes in Self-Injury Trauma Scale (SIT) across time
timeFrame: Baseline and weeks 7, 11, 6 months, and 12 months
Secondary outcomes:
measure: Changes in Daily Diary Card across time
timeFrame: Baseline and weeks 2, 3, 4, 5, 6, 7, 11, 6 months, and 12 months
measure: Changes in Repetitive Behavior Scale-Revised (RBS-R) across time
timeFrame: Baseline and weeks 7, 11, 6 months, and 12 months
measure: Changes in Aberrant Behavior Checklist (ABC) across time
timeFrame: Baseline and weeks 7, 11, 6 months, and 12 months
measure: Changes in ASD Diagnostic Checklist (ADC) across time
timeFrame: Baseline and weeks 7, 11, 6 months, and 12 months
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Shriti Patel, MD
role: PRINCIPAL_INVESTIGATOR
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