- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03980366
Use of Electroconvulsive Therapy to Treat Self-Injurious Behavior in Adults With Autism Spectrum Disorders
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Bilateral Electroconvulsive Therapy (ECT) to treat self-injurious behavior in adults with Autism Spectrum Disorder (ASD).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
Baseline and weeks 7, 11, 6 months, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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:
|
Baseline and weeks 7, 11, 6 months, and 12 months
|
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). |
Baseline and weeks 7, 11, 6 months, and 12 months
|
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) |
Baseline and weeks 7, 11, 6 months, and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shriti Patel, MD, Eastern Virginia Medical School
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Dhossche DM. Autism as early expression of catatonia. Med Sci Monit. 2004 Mar;10(3):RA31-9. Epub 2004 Mar 1.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECT4ASD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Self-Injurious Behavior
-
New York State Psychiatric InstituteMINT: Mental Health InitiativeCompletedInterpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury (IPT-ASI)Depression | Self-injurious BehaviorUnited States
-
Western Michigan University School of MedicineKalamazoo Community FoundationWithdrawnSelf Mutilation | Self-injurious BehaviorUnited States
-
Hartford HospitalOui Therapeutics, LLCNot yet recruitingSuicidal and Self-injurious BehaviorUnited States
-
White River Junction Veterans Affairs Medical CenterUS Department of Veterans AffairsActive, not recruitingSuicidal and Self-injurious BehaviorUnited States
-
Boston University Charles River CampusNational Institute of Mental Health (NIMH)CompletedSelf Injurious Behavior Without Suicidal IntentUnited States
-
Region SkaneLund UniversityCompletedSuicidal Ideation | Self-Harm, Deliberate | Self Injurious Behavior Without Suicidal IntentSweden
-
University Hospital, MontpellierRecruitingMajor Depressive Episode | Suicidal and Self-injurious BehaviorFrance
-
Rutgers, The State University of New JerseyRecruiting
-
University Medical Centre MariborFaculty of Medicine, University of MariborCompletedSelf-Injurious Behavior | Self Injurious Behavior Without Suicidal Intent
-
Northeastern UniversityHarvard School of Public Health (HSPH); American Foundation for Suicide Prevention and other collaboratorsCompletedSuicidal and Self-injurious BehaviorUnited States
Clinical Trials on Electroconvulsive Therapy (ECT)
-
Shanghai Mental Health CenterCompleted
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)Completed
-
Radboud University Medical CenterUMC Utrecht; St. Antonius Hospital; Canisius-Wilhelmina Hospital; GGZ inGeest; ETZRecruitingDepressive Disorder, MajorNetherlands
-
Wake Forest University Health SciencesTerminated
-
Centre for Addiction and Mental HealthUniversity of British Columbia; Brain Canada; Ontario Shores Centre for Mental...Active, not recruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
-
University of IowaNot yet recruitingSuicide | Major Depressive Disorder
-
Brent ForesterMedical University of South Carolina; Mayo Clinic; Emory University; The Zucker... and other collaboratorsRecruitingAlzheimer Dementia | Agitation,PsychomotorUnited States
-
Region Örebro CountyRecruitingDepressive Disorder, Major | Depression, BipolarSweden
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloRecruitingBipolar Depression | Major Depressive DisorderBrazil