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

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ClinicalTrials.gov Identifier: NCT03980366
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Sentara Norfolk General Hospital
Information provided by (Responsible Party):
Eastern Virginia Medical School

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Self-Injurious Behavior Device: Electroconvulsive Therapy (ECT) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Electroconvulsive Therapy to Treat Self-Injurious Behavior in Adults With Autism Spectrum Disorders
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ECT to treat self-injurious behaviors in adults with ASD
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.
Device: Electroconvulsive Therapy (ECT)
Bilateral Electroconvulsive Therapy (ECT) to treat self-injurious behavior in adults with Autism Spectrum Disorder (ASD).




Primary Outcome Measures :
  1. Changes in Self-Injury Trauma Scale (SIT) across time [ Time Frame: 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)


Secondary Outcome Measures :
  1. Changes in Daily Diary Card across time [ Time Frame: Baseline and weeks 2, 3, 4, 5, 6, 7, 11, 6 months, and 12 months ]
    A daily diary card used to record the number of self-injury episodes, the number of aggressive episodes, and the perceived severity of episodes per day.

  2. Changes in Repetitive Behavior Scale-Revised (RBS-R) across time [ Time Frame: Baseline and weeks 7, 11, 6 months, and 12 months ]

    The 43-item revised scale is specifically intended to assess the variety of repetitive behaviors in individuals with ASD, grouped into 6 categories: 1) stereotyped behavior, 2) self-injurious behavior, 3) compulsive behavior, 4) ritualistic behavior, 5) sameness behavior, and 6) restricted injurious behavior.

    All items are scored from 0 (behavior does not occur) to 1 (behavior occurs and is a mild problem) to 2 (behavior occurs and is a moderate problem) to 3 (behavior occurs and is a severe problem).

    Scale scores for the above 6 scales include:

    • Number of Subscale Items Endorsed: The total number of items in each scale rated 1, 2, or 3 (per scale)
    • Total Subscale Score: The sum of the ratings for all items in that scale (per scale)
    • Overall Number of Items Endorsed: The sum of all "Number of Subscale Items Endorsed" (combined scales Total score)
    • Overall Score: The sum of all "Total Subscale Scores" (combined scales Total score)

  3. Changes in Aberrant Behavior Checklist (ABC) across time [ Time Frame: Baseline and weeks 7, 11, 6 months, and 12 months ]

    A 58-item measure useful for evaluation inappropriate and maladaptive behavior with five subscales: 1) Irritability, Agitation, Crying; 2) Lethargy, Social Withdrawal; 3) Stereotypic Behavior; 4) Hyperactivity, Noncompliance; and 5) Inappropriate Speech.

    All items are scored from 0 (Not at all a problem) to 3 (the problem is severe in degree).

    Each of the 5 scales includes a sum of scores for items on that scale, ranging from [0] (no problem with this measure) to [12 to 48, depending on the scale] (severe problem with this measure).


  4. Changes in ASD Diagnostic Checklist (ADC) across time [ Time Frame: Baseline and weeks 7, 11, 6 months, and 12 months ]

    A 30-item instrument designed after the ADOS (Autism Diagnostic Observation Schedule), ADI-R (Autism Diagnostic Interview-Revised), and DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) criteria for autism, used to assess: 1) qualitative impairment in social interaction, 2) difficulties in communication, and 3) restricted, repetitive and stereotyped patterns of behavior.

    All items are scored "Yes" or "No".

    Scale scores are the sum of the number of "Yes" responses for each scale. Scores range from [0] (zero "Yes" responses equivalent to no ASD-related behaviors) to [6 to 14, depending on the scale] (all "Yes" responses equivalent to higher ASD-related behaviors).

    Total Score includes the sum of all items with a "Yes" response, ranging from 0 (no ASD-related behaviors) to 30 (higher ASD-related behaviors)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980366


Contacts
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Contact: Shriti Patel, MD 757-446-5888 patelsb@evms.edu
Contact: Betsy Conner 757-446-5854 connerbc@evms.edu

Locations
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United States, Virginia
Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23507
Contact: Shriti B Patel, MD    757-446-5888    PatelSB@evms.edu   
Contact: Betsy C Conner    757-446-5854    ConnerBC@evms.edu   
Sponsors and Collaborators
Eastern Virginia Medical School
Sentara Norfolk General Hospital
Investigators
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Principal Investigator: Shriti Patel, MD Eastern Virginia Medical School
  Study Documents (Full-Text)

Documents provided by Eastern Virginia Medical School:
Study Protocol  [PDF] December 20, 2016
Informed Consent Form  [PDF] December 20, 2016


Publications:

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Responsible Party: Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT03980366     History of Changes
Other Study ID Numbers: ECT4ASD
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Eastern Virginia Medical School:
Electroconvulsive Therapy
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Self-Injurious Behavior
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Behavioral Symptoms