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

NCT03980366 | Terminated FDA Device

• 1 other identifier: ECT4ASD
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Self-Injurious Behavior

Keywords

Electroconvulsive Therapy

Outcome Measures

Primary Outcomes (1)

• Changes in Self-Injury Trauma Scale (SIT) across time

  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)

  Baseline and weeks 7, 11, 6 months, and 12 months

Secondary Outcomes (4)

• 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 Aberrant Behavior Checklist (ABC) 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

Study Arms (1)

ECT to treat self-injurious behaviors in adults with ASD

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.

Device: Electroconvulsive Therapy (ECT)

Interventions

Electroconvulsive Therapy (ECT) DEVICE

Bilateral Electroconvulsive Therapy (ECT) to treat self-injurious behavior in adults with Autism Spectrum Disorder (ASD).

ECT to treat self-injurious behaviors in adults with ASD

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• Sentara Norfolk General Hospital: collaborator

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (21)

• Tate BG, Baroff GS. Aversive control of self-injurious behavior in a psychotic boy. Behav Res Ther. 1966 Nov;4(4):281-7. doi: 10.1016/0005-7967(66)90024-6. No abstract available.

  PMID: 5978683 BACKGROUND

• Iwata BA, Pace GM, Kissel RC, Nau PA, Farber JM. The Self-Injury Trauma (SIT) Scale: a method for quantifying surface tissue damage caused by self-injurious behavior. J Appl Behav Anal. 1990 Spring;23(1):99-110. doi: 10.1901/jaba.1990.23-99.

  PMID: 2335488 BACKGROUND

• Wachtel LE, Dhossche DM. Self-injury in autism as an alternate sign of catatonia: implications for electroconvulsive therapy. Med Hypotheses. 2010 Jul;75(1):111-4. doi: 10.1016/j.mehy.2010.02.001. Epub 2010 Mar 3.

  PMID: 20202760 BACKGROUND

• Dhossche DM, Carroll BT, Carroll TD. Is there a common neuronal basis for autism and catatonia? Int Rev Neurobiol. 2006;72:151-64. doi: 10.1016/S0074-7742(05)72009-2.

  PMID: 16697296 BACKGROUND

• Dhossche DM. Autism as early expression of catatonia. Med Sci Monit. 2004 Mar;10(3):RA31-9. Epub 2004 Mar 1.

  PMID: 14976444 BACKGROUND

• Chagnon YC. Shared susceptibility region on chromosome 15 between autism and catatonia. Int Rev Neurobiol. 2006;72:165-78. doi: 10.1016/S0074-7742(05)72010-9.

  PMID: 16697297 BACKGROUND

• Hawkins JM, Archer KJ, Strakowski SM, Keck PE. Somatic treatment of catatonia. Int J Psychiatry Med. 1995;25(4):345-69. doi: 10.2190/X0FF-VU7G-QQP7-L5V7.

  PMID: 8822386 BACKGROUND

• Rohland BM, Carroll BT, Jacoby RG. ECT in the treatment of the catatonic syndrome. J Affect Disord. 1993 Dec;29(4):255-61. doi: 10.1016/0165-0327(93)90015-c.

  PMID: 8126312 BACKGROUND

• Haq AU, Ghaziuddin N. Maintenance electroconvulsive therapy for aggression and self-injurious behavior in two adolescents with autism and catatonia. J Neuropsychiatry Clin Neurosci. 2014 Winter;26(1):64-72. doi: 10.1176/appi.neuropsych.12110284.

  PMID: 24515677 BACKGROUND

• Wachtel LE, Contrucci-Kuhn SA, Griffin M, Thompson A, Dhossche DM, Reti IM. ECT for self-injury in an autistic boy. Eur Child Adolesc Psychiatry. 2009 Jul;18(7):458-63. doi: 10.1007/s00787-009-0754-8. Epub 2009 Feb 5.

  PMID: 19198918 BACKGROUND

• Wachtel LE, Griffin M, Reti IM. Electroconvulsive therapy in a man with autism experiencing severe depression, catatonia, and self-injury. J ECT. 2010 Mar;26(1):70-3. doi: 10.1097/YCT.0b013e3181a744ec.

  PMID: 19483640 BACKGROUND

• Wachtel LE, Schuldt S, Ghaziuddin N, Shorter E. The potential role of electroconvulsive therapy in the 'Iron Triangle' of pediatric catatonia, autism, and psychosis. Acta Psychiatr Scand. 2013 Nov;128(5):408-9. doi: 10.1111/acps.12158. Epub 2013 Jun 17. No abstract available.

  PMID: 23773168 BACKGROUND

• Zaw FK, Bates GD, Murali V, Bentham P. Catatonia, autism, and ECT. Dev Med Child Neurol. 1999 Dec;41(12):843-5. doi: 10.1017/s001216229900167x.

  PMID: 10619284 BACKGROUND

• DeJong H, Bunton P, Hare DJ. A systematic review of interventions used to treat catatonic symptoms in people with autistic spectrum disorders. J Autism Dev Disord. 2014 Sep;44(9):2127-36. doi: 10.1007/s10803-014-2085-y.

  PMID: 24643578 BACKGROUND

• Lam KS, Aman MG. The Repetitive Behavior Scale-Revised: independent validation in individuals with autism spectrum disorders. J Autism Dev Disord. 2007 May;37(5):855-66. doi: 10.1007/s10803-006-0213-z.

  PMID: 17048092 BACKGROUND

• Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985 Mar;89(5):485-91.

  PMID: 3993694 BACKGROUND

• Dhossche DM, Reti IM, Wachtel LE. Catatonia and autism: a historical review, with implications for electroconvulsive therapy. J ECT. 2009 Mar;25(1):19-22. doi: 10.1097/YCT.0b013e3181957363.

  PMID: 19190507 BACKGROUND

• Leyfer OT, Folstein SE, Bacalman S, Davis NO, Dinh E, Morgan J, Tager-Flusberg H, Lainhart JE. Comorbid psychiatric disorders in children with autism: interview development and rates of disorders. J Autism Dev Disord. 2006 Oct;36(7):849-61. doi: 10.1007/s10803-006-0123-0.

  PMID: 16845581 BACKGROUND

• Mandell DS. Psychiatric hospitalization among children with autism spectrum disorders. J Autism Dev Disord. 2008 Jul;38(6):1059-65. doi: 10.1007/s10803-007-0481-2. Epub 2007 Nov 2.

  PMID: 17975720 BACKGROUND

• Aman MG, Kasper W, Manos G, Mathew S, Marcus R, Owen R, Mankoski R. Line-item analysis of the Aberrant Behavior Checklist: results from two studies of aripiprazole in the treatment of irritability associated with autistic disorder. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):415-22. doi: 10.1089/cap.2009.0120.

  PMID: 20973712 BACKGROUND

• Kaat AJ, Lecavalier L, Aman MG. Validity of the aberrant behavior checklist in children with autism spectrum disorder. J Autism Dev Disord. 2014 May;44(5):1103-16. doi: 10.1007/s10803-013-1970-0.

  PMID: 24165702 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Shriti Patel, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: June 10, 2019
• Study Start: March 15, 2019
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: June 24, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)