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Self-Injury: Diagnosis and Treatment

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ClinicalTrials.gov Identifier: NCT00065936
Recruitment Status : Unknown
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Active, not recruiting
First Posted : August 5, 2003
Last Update Posted : June 24, 2005
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
Self-injurious behavior is behavior in which a person hurts or harms himself. This behavior sometimes occurs in people with mental retardation or autism. This study will evaluate self-injurious behavior in people with mental retardation or autism and will test the effectiveness of new treatments.

Condition or disease Intervention/treatment Phase
Self-Injurious Behavior Mental Retardation Drug: Naltrexone hydrochloride Procedure: Transcutaneous sensory nerve stimulation Phase 3

Detailed Description:

It is unknown why some people with mental retardation and/or autism repeatedly and persistently injure themselves, some to the point of tissue damage and permanent scarring. Unraveling this mystery poses paradoxical biomedical and behavioral science questions and creates deeply troubling problems for practitioners and family members of affected individuals. Over the past decade, many cases of self-injurious behavior (SIB) have been treated successfully using behavioral interventions that teach communication and other functional skills. However, practical problems of implementation, costs associated with long-term treatment, and cases with no clear social profile suggest that there is still much to be learned about why people self-injure. Some forms of self-injury may involve intense stimulation of body sites sufficient to elicit the release and receptor binding of endogenous opioid peptides. This study will evaluate variables common to SIB and the neurophysiology of pain regulation. The study will also clarify the role of the endogenous opioids and pain mechanisms in self-injury.

Participants with mild to profound mental retardation and/or autism will be observed for frequency of self-injury, duration and intensity of self-injurious behavior, and where on the body that behavior is directed. Following this characterization, participants’ saliva will be noninvasively examined for substance P, met-enkephalin, and cortisol as markers for altered pain transmission and predictors of response to treatment. After screening and SIB subtyping (i.e., social, nonsocial, or mixed), 37 participants whose self-injury is primarily nonsocial or mixed will be evaluated over 16 weeks. Participants will be randomized to receive either transcutaneous electric nerve stimulation (TENS, an opioid agonist treatment) or naltrexone (an opioid antagonist treatment). Participants whose self-injury is primarily socially motivated will be evaluated with TENS and will receive behavioral interventions through a technical assistance service delivery model. Follow-up evaluations will occur at Months 3 and 6.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Behavioral and Biochemical Mechanisms of Self-Injury
Study Start Date : July 1997
Estimated Study Completion Date : June 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Self-injurious behavior for at least 3 months prior to study entry
  • Normal cardiac, liver, and kidney function as determined by a physician

Exclusion Criteria

  • Only presenting problems are pica, aggression, property destruction, hyperkinesis, screaming, or eating disorders
  • Lesch-Nyhan syndrome
  • Peripheral neuropathy
  • Self-injury that presents immediate imminent risk such as loss of sight or hearing or other potentially life threatening behavior
  • Serious chronic health impairments associated with specific syndromes (e.g., Cornelia de Lange, Prader Willi Syndrome)
  • Self-injury unresponsive to prior conventional behavioral or pharmacological interventions (e.g., less than 50% reduction in overall self-injury for 3 months)
  • Major depressive disorder or schizophrenia

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): NCT00065936

United States, North Carolina
Frank Porter Graham Child Development Center, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Research Training Institute, Western Carolina Center
Morganton, North Carolina, United States, 28655
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Frank Symons, Ph.D. University of North Carolina

ClinicalTrials.gov Identifier: NCT00065936     History of Changes
Other Study ID Numbers: R29HD35862
R29 HD35862
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2003

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Intractable self-injurious behavior
Transcutaneous electrical nerve stimulation
Substance P

Additional relevant MeSH terms:
Intellectual Disability
Self-Injurious Behavior
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Behavioral Symptoms
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents