AutismPhase 2NCT01388179
Deep rTMS (Repetitive Transcranial Magnetic Stimulation)for Treatment of Autism Symptoms in Children.
A Phase 2 study testing Transcranial Magnetic Stimulation in people with Autism, run by Brainsway at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Autism
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jan 2013to 31 Dec 2016
- Phase
- Phase 2
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep rTMS(Repetitive Transcranial Magnetic Stimulation) for Treatment of Autism Symptoms in Children With Low Functioning ASD (Autism Spectrum Disorders)
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.
Read more
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.
- Conditions
- Autism
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Autism, TMS
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
low-frequency rTMS to the left DLPFC prior to high-frequency deep rTMS to the FFA through the STS.
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS treatment | Active comparator | 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). Receives: Device: Transcranial Magnetic Stimulation |
| Sham rTMS treatment | Sham comparator | Sham coil which simulate the real coil action Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days from first day of treatment
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.
Measured: 90 days from first day of treatment
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.
Measured: 90 days from first day of treatment
Secondary outcomes (3)
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)
Measured: 90 days from first treatment
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)
Measured: 90 days from first day of treatment
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.
Measured: 90 days from first day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study start23 Jan 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: Sponsor decision to stop the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388179
- Sponsor's protocol ID
- TMS-AUTISM
- Status last verified
- Apr 2018
- First submitted
- 27 Jun 2011
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep rTMS(Repetitive Transcranial Magnetic Stimulation) for Treatment of Autism Symptoms in Children With Low Functioning ASD (Autism Spectrum Disorders)
- ClinicalTrials.gov ID
- NCT01388179
- Acronym / sponsor ID
- TMS-AUTISM
- Conditions
- Autism
- Keywords
- Autism, TMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to stop the study
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- 23 Jan 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 6 Jul 2011 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real rTMS treatment | Active comparator | Device: Transcranial Magnetic Stimulationlow-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 rTMS treatment | Sham comparator | Device: Transcranial Magnetic StimulationSham coil which simulate the real coil action |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (16 listed)
- 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)
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 |
|---|---|---|
| Transcranial Magnetic Stimulationlow-frequency rTMS to the left DLPFC prior to high-frequency deep rTMS to the FFA through the STS. | Device | Real rTMS treatment, Sham rTMS treatment |
Primary outcome
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.
3 secondary outcomes
PLS-4(Preschool Language Scale - 4 ) as a measure for language impairment.
Time frame: 90 days from first treatment
BASC (Behavior Assessment System for Children) as a measure for anxiety
Time frame: 90 days from first day of treatment
ABC (Autism Behavior Checklist)as a measure for repetitive behaviors
Time frame: 90 days from first day of treatment
Results and safety
The study was stopped early (reason given: Sponsor decision to stop the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial Magnetic Stimulation in people with Autism, run by Brainsway at 1 site in Israel.
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 6 inclusion and 16 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 17 Apr 2018. 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision to stop the 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?
CGI-I(clinical global impression-I) as a measure for social functioning (time frame: 90 days from first day of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2018.