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

Primary Purpose

Autism

Status

Terminated

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, TMS

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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)
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.
Have normal physical examination.
TAS (Transcranial magnetic stimulation Safety Screen questionnaire) is negative or mitigated as per parent prior to the study.

Exclusion Criteria:

Patients born prior to 37 weeks gestational age.
Patients with any primary psychiatric diagnosis other than autism at screening.
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.
Patients with a medical history of epilepsy/seizure disorder
Patients with a family history of epilepsy in a first degree relative (parent or sibling)
Patients with a medical condition other then autism
Patients prescribed with psychoactive medication(s) less then 4 weeks prior to joining the study.
Patients with a medical history head trauma associated with prolonged loss of consciousness.
History of metal foreign body in the head, excluding oral devices
History of known anatomical brain abnormality
Hearing loss
participation in an ongoing other interventional study

Discontinuation criteria:

The patient or legal guardian refuses to continue
The RC decides that the patient is not suitable to continue the study
Severe side effects

Sites / Locations

Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real rTMS treatment

Sham rTMS treatment

Arm Description

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).

Sham coil which simulate the real coil action

Outcomes

Primary Outcome Measures

CGI-I(clinical global impression-I) as a measure for social functioning

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

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

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.

Secondary Outcome Measures

PLS-4(Preschool Language Scale - 4 ) as a measure for language impairment.

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

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

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.

Full Information

NCT ID

NCT01388179

First Posted

June 27, 2011

Last Updated

April 15, 2018

Sponsor

Brainsway

Collaborators

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01388179

Brief Title

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

Official Title

Deep rTMS(Repetitive Transcranial Magnetic Stimulation) for Treatment of Autism Symptoms in Children With Low Functioning ASD (Autism Spectrum Disorders)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision to stop the study

Study Start Date

January 23, 2013 (Actual)

Primary Completion Date

December 31, 2016 (Actual)

Study Completion Date

December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brainsway

Collaborators

Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism

Keywords

Autism, TMS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Real rTMS treatment

Arm Type

Active Comparator

Arm Description

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).

Arm Title

Sham rTMS treatment

Arm Type

Sham Comparator

Arm Description

Sham coil which simulate the real coil action

Intervention Type

Device

Intervention Name(s)

Transcranial Magnetic Stimulation

Intervention Description

low-frequency rTMS to the left DLPFC prior to high-frequency deep rTMS to the FFA through the STS.

Primary Outcome Measure Information:

Title

CGI-I(clinical global impression-I) as a measure for social functioning

Description

rTMS treatment will be superior to sham treatment in improving social functioning (using the CGI-I Social) in children and adolescents with ASD.

Time Frame

90 days from first day of treatment

Title

ASRS (Adult ADHD Self Report Scale) as a measure for social awareness and social motivation

Description

rTMS treatment will be superior to sham treatment in improving social awareness and social motivation (using the ASRS) in children and adolescents with ASD.

Time Frame

90 days from first day of treatment

Title

Facial recognition test as a measure for preference to faces vs. objects

Description

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.

Time Frame

90 days from first day of treatment

Secondary Outcome Measure Information:

Title

PLS-4(Preschool Language Scale - 4 ) as a measure for language impairment.

Description

rTMS treatment will be superior to sham treatment in the treatment of language impairment (using the PLS-4 Hebrew language assessment)

Time Frame

90 days from first treatment

Title

BASC (Behavior Assessment System for Children) as a measure for anxiety

Description

rTMS will be superior to sham in the treatment of the associated autism symptom domains of anxiety (BASC-anxiety subscale)

Time Frame

90 days from first day of treatment

Title

ABC (Autism Behavior Checklist)as a measure for repetitive behaviors

Description

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.

Time Frame

90 days from first day of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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) 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. Have normal physical examination. TAS (Transcranial magnetic stimulation Safety Screen questionnaire) is negative or mitigated as per parent prior to the study. Exclusion Criteria: Patients born prior to 37 weeks gestational age. Patients with any primary psychiatric diagnosis other than autism at screening. 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. Patients with a medical history of epilepsy/seizure disorder Patients with a family history of epilepsy in a first degree relative (parent or sibling) Patients with a medical condition other then autism Patients prescribed with psychoactive medication(s) less then 4 weeks prior to joining the study. Patients with a medical history head trauma associated with prolonged loss of consciousness. History of metal foreign body in the head, excluding oral devices History of known anatomical brain abnormality Hearing loss participation in an ongoing other interventional study Discontinuation criteria: The patient or legal guardian refuses to continue The RC decides that the patient is not suitable to continue the study Severe side effects

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

12. IPD Sharing Statement

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

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