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Deep rTMS (Repetitive Transcranial Magnetic Stimulation)for Treatment of Autism Symptoms in Children.

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ClinicalTrials.gov Identifier: NCT01388179
Recruitment Status : Terminated (Sponsor decision to stop the study)
First Posted : July 6, 2011
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by (Responsible Party):
Brainsway

Tracking Information
First Submitted Date  ICMJE June 27, 2011
First Posted Date  ICMJE July 6, 2011
Last Update Posted Date April 17, 2018
Actual Study Start Date  ICMJE January 23, 2013
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2011)
  • CGI-I(clinical global impression-I) as a measure for social functioning [ Time Frame: 90 days from first day of treatment ]
    rTMS treatment will be superior to sham treatment in improving social functioning (using the CGI-I Social) in children and adolescents with ASD.
  • ASRS (Adult ADHD Self Report Scale) as a measure for social awareness and social motivation [ Time Frame: 90 days from first day of treatment ]
    rTMS treatment will be superior to sham treatment in improving social awareness and social motivation (using the ASRS) in children and adolescents with ASD.
  • Facial recognition test as a measure for preference to faces vs. objects [ Time Frame: 90 days from first day of treatment ]
    rTMS treatment will be superior to sham treatment in increasing preference to faces vs. objects as measured by a facial recognition test, in children and adolescents with ASD.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01388179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2011)
  • PLS-4(Preschool Language Scale - 4 ) as a measure for language impairment. [ Time Frame: 90 days from first treatment ]
    rTMS treatment will be superior to sham treatment in the treatment of language impairment (using the PLS-4 Hebrew language assessment)
  • BASC (Behavior Assessment System for Children) as a measure for anxiety [ Time Frame: 90 days from first day of treatment ]
    rTMS will be superior to sham in the treatment of the associated autism symptom domains of anxiety (BASC-anxiety subscale)
  • ABC (Autism Behavior Checklist)as a measure for repetitive behaviors [ Time Frame: 90 days from first day of treatment ]
    rTMS treatment will be superior to sham treatment in the treatment of repetitive behaviors (using the Aberrant Behavior Checklist -ABC) in children and adolescents with ASD.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep rTMS (Repetitive Transcranial Magnetic Stimulation)for Treatment of Autism Symptoms in Children.
Official Title  ICMJE Deep rTMS(Repetitive Transcranial Magnetic Stimulation) for Treatment of Autism Symptoms in Children With Low Functioning ASD (Autism Spectrum Disorders)
Brief Summary

Autism is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning, and repetitive behaviors and interests. The term "Autism spectrum disorders" or ASD is often used to include autistic disorder, Asperger syndrome and pervasive developmental disorder-not otherwise specified (PDD-NOS). Epidemiological research suggests that ASDs affect at least 60 per 10,000 youth, with estimates as high as 120 per 10,000.

Severity of autistic features is not easily defined and the use of different diagnostic tools compounds the ability to lay a clear cut definition. It is, though, generally accepted that children with autism and normal IQ (>70) are "high functioning" regardless of the severity of their autistic features. The investigators will use the terms "autism" and "ASD" interchangeably, and the term "low functioning autism" will be used to describe those children with autism who have, or are presumed to have, IQ<70.

The pathophysiology of autism has been studied extensively in the last decade. Abnormal neuronal connectivity has been implicated in a growing body of research. In addition, areas of over and/or under neuronal activation have been detected on functional MRI(Magnetic Resonance Imaging).

Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive technique that allows to affect brain activity. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating the neurons in the relevant brain structure.

rTMS has been studied in individuals with high functioning autism. rTMS treatment was found to have an electrophysiological effect and to reduce repetitive behaviors and improved social functioning.

In the context of existing pilot data suggesting effect of rTMS treatment in individuals with high functioning autism, the investigators propose a pilot study to assess the efficacy of rTMS in children and adolescents with low functioning autism.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE Device: Transcranial Magnetic Stimulation
low-frequency rTMS to the left DLPFC prior to high-frequency deep rTMS to the FFA through the STS.
Study Arms  ICMJE
  • Active Comparator: Real rTMS treatment
    low-frequency rTMS to the left DLPFC (Dorsa-Lateral Pre-Frontal Cortex) prior to high-frequency deep rTMS to the FFA (Fusi-Form Area) through the STS(Superior Temporal Sulcus).
    Intervention: Device: Transcranial Magnetic Stimulation
  • Sham Comparator: Sham rTMS treatment
    Sham coil which simulate the real coil action
    Intervention: Device: Transcranial Magnetic Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: July 5, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female outpatients 10-19 years of age. Although we assume that the effect of rTMS may be greater in younger children, in whom secondary behavioral issues may be less established, the study will focus on children older than age 10 years for 2 reasons:

    i. Some cooperation is needed by the children to undergo a rTMS treatment. ii. We would like to establish the efficacy and safety profile of this treatment in older children with autism before we expose younger children, who may need sedation, to it.

  2. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria. Children will have had a diagnosis of ASD prior to the study given by a pediatric neurologist, child psychiatrist or developmental pediatrician. Diagnosis will be confirmed by Autism Diagnostic Observation Schedule (ADOS-G) and Autism Diagnostic Interview (ADI-R)
  3. VABS-II score in the low-very low range. This study is recruiting low functioning individuals with Autism. Although some of the assessment tools (i.e. ASRS) are standardized and validated on individuals without intellectual disabilities, there has been experience using these tools in children with autism in all intellectual levels. In addition, because we are measuring a change over time and not endorsing a diagnosis, we feel that using these tools is sufficient.
  4. Have normal physical examination.
  5. TAS (Transcranial magnetic stimulation Safety Screen questionnaire) is negative or mitigated as per parent prior to the study.

Exclusion Criteria:

  1. Patients born prior to 37 weeks gestational age.
  2. Patients with any primary psychiatric diagnosis other than autism at screening.
  3. Patients with a medical history of neurological disease, including, but not limited to, movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain or a history of traumatic brain injury.
  4. Patients with a medical history of epilepsy/seizure disorder
  5. Patients with a family history of epilepsy in a first degree relative (parent or sibling)
  6. Patients with a medical condition other then autism
  7. Patients prescribed with psychoactive medication(s) less then 4 weeks prior to joining the study.
  8. Patients with a medical history head trauma associated with prolonged loss of consciousness.
  9. History of metal foreign body in the head, excluding oral devices
  10. History of known anatomical brain abnormality
  11. Hearing loss
  12. participation in an ongoing other interventional study

Discontinuation criteria:

  1. The patient or legal guardian refuses to continue
  2. The RC decides that the patient is not suitable to continue the study
  3. Severe side effects
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01388179
Other Study ID Numbers  ICMJE TMS-AUTISM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brainsway
Study Sponsor  ICMJE Brainsway
Collaborators  ICMJE Hadassah Medical Organization
Investigators  ICMJE Not Provided
PRS Account Brainsway
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP