Autism Spectrum DisorderNCT03980366
Use of Electroconvulsive Therapy to Treat Self-Injurious Behavior in Adults With Autism Spectrum Disorders
A study testing Electroconvulsive Therapy (ECT) in people with Autism Spectrum Disorder and Self-Injurious Behavior, run by Eastern Virginia Medical School at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Autism Spectrum Disorder, Self-Injurious Behavior
- What is being tested?
- Electroconvulsive Therapy (ECT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2019to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Self-Injurious Behavior
- Being tested
- Electroconvulsive Therapy (ECT)
- Keywords
- Electroconvulsive Therapy
- Medical subject headings
- Autism Spectrum Disorder, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive Therapy (ECT)Device
Bilateral Electroconvulsive Therapy (ECT) to treat self-injurious behavior in adults with Autism Spectrum Disorder (ASD).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electroconvulsive Therapy (ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and weeks 7, 11, 6 months, and 12 months
Secondary outcomes (4)
Changes in Daily Diary Card across time
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.
Measured: 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
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)
Measured: Baseline and weeks 7, 11, 6 months, and 12 months
Changes in Aberrant Behavior Checklist (ABC) across time
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).
Measured: Baseline and weeks 7, 11, 6 months, and 12 months
Changes in ASD Diagnostic Checklist (ADC) across time
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)
Measured: Baseline and weeks 7, 11, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start15 Mar 2019
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Why it stopped: We have not obtained additional subjects and chose to terminate/close this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Sentara Norfolk General Hospital
- Responsible party
- Sponsor
- Investigators
- Shriti Patel, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980366
- Sponsor's protocol ID
- ECT4ASD
- Status last verified
- Jul 2020
- First submitted
- 11 Apr 2019
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 5978683Iwata 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.
PubMed 2335488Wachtel 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.
PubMed 20202760Dhossche 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.
PubMed 16697296Dhossche DM. Autism as early expression of catatonia. Med Sci Monit. 2004 Mar;10(3):RA31-9. Epub 2004 Mar 1.
PubMed 14976444Chagnon 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.
PubMed 16697297Hawkins 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.
PubMed 8822386Rohland 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.
PubMed 8126312Haq 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.
PubMed 24515677Wachtel 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.
PubMed 19198918Wachtel 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.
PubMed 19483640Wachtel 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.
PubMed 23773168Zaw 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.
PubMed 10619284DeJong 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.
PubMed 24643578Lam 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.
PubMed 17048092
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Electroconvulsive Therapy to Treat Self-Injurious Behavior in Adults With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT03980366
- Acronym / sponsor ID
- ECT4ASD
- Conditions
- Autism Spectrum Disorder, Self-Injurious Behavior
- Keywords
- Electroconvulsive Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We have not obtained additional subjects and chose to terminate/close this study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- Sentara Norfolk General Hospital
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| ECT to treat self-injurious behaviors in adults with ASD | Experimental | Device: Electroconvulsive Therapy (ECT)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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive Therapy (ECT)Bilateral Electroconvulsive Therapy (ECT) to treat self-injurious behavior in adults with Autism Spectrum Disorder (ASD). | Device | ECT to treat self-injurious behaviors in adults with ASD |
Primary outcome
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)
4 secondary outcomes
Changes in Daily Diary Card across time
Time frame: 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
Changes in Aberrant Behavior Checklist (ABC) across time
Time frame: 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
Results and safety
The study was stopped early (reason given: We have not obtained additional subjects and chose to terminate/close this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Background: PubMed 5978683Tate 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.
- Background: PubMed 2335488Iwata 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.
- Background: PubMed 20202760Wachtel 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.
- Background: PubMed 16697296Dhossche 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.
- Background: PubMed 14976444Dhossche DM. Autism as early expression of catatonia. Med Sci Monit. 2004 Mar;10(3):RA31-9. Epub 2004 Mar 1.
- Background: PubMed 16697297Chagnon 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.
- Background: PubMed 8822386Hawkins 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.
- Background: PubMed 8126312Rohland 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.
- Background: PubMed 24515677Haq 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.
- Background: PubMed 19198918Wachtel 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.
- Background: PubMed 19483640Wachtel 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.
- Background: PubMed 23773168Wachtel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shriti Patel, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroconvulsive Therapy (ECT) in people with Autism Spectrum Disorder and Self-Injurious Behavior, run by Eastern Virginia Medical School at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We have not obtained additional subjects and chose to terminate/close this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Self-Injury Trauma Scale (SIT) across time (time frame: Baseline and weeks 7, 11, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03980366, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.