Use of Electroconvulsive Therapy to Treat Self-Injurious Behavior in Adults With Autism Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Changes in Self-Injury Trauma Scale (SIT) across time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in Self-Injury Trauma Scale (SIT) across time
时间窗: Baseline and weeks 7, 11, 6 months, and 12 months
Self-Injury Trauma Scale (SIT). This scale allows differentiation and quantification of self-injury completed by the physician based on a complete medical assessment, location of injury, type of injury, number of injuries, and an estimate of severity. Scales include: * Number Index (NI) - Scores range from 0 (no current injuries) to 5 (17 or more current injuries) * Severity Index (SI) - Scores range from 0 (no current injuries) to 5 (maximum severity of current injuries) * Estimate of Current Risk - Scores range from Low (no current injuries or a lower level of injuries) to Moderate (any abrasion/laceration near the eyes OR any contusion except on the head) to High (any moderate contusion on the head OR any severe abrasion/laceration or contusion)
次要结局
- Changes in Daily Diary Card across time(Baseline and weeks 2, 3, 4, 5, 6, 7, 11, 6 months, and 12 months)
- Changes in Repetitive Behavior Scale-Revised (RBS-R) across time(Baseline and weeks 7, 11, 6 months, and 12 months)
- Changes in ASD Diagnostic Checklist (ADC) across time(Baseline and weeks 7, 11, 6 months, and 12 months)
- Changes in Aberrant Behavior Checklist (ABC) across time(Baseline and weeks 7, 11, 6 months, and 12 months)