Autism Spectrum DisorderNCT02836405
TMS for the Investigation of Brain Plasticity in Autism Spectrum Disorders
An observational study of Autism Spectrum Disorder and Intellectual Disability, run by Boston Children's Hospital at 2 sites in United States.
Trial summary
The main purpose is to study brain plasticity (the changes that occur in the brain through experience) in individuals with autism spectrum disorder (ASD). Research suggests that during development, the brains of individuals with ASD may change in response to their experiences differently than the brains of typically… Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Intellectual Disability
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 164 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Jul 2020
- Phase
- Observational
- 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 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children and adults diagnosed with an Autism Spectrum Disorder (ASD), as well as controls.
Who may be able to join
None listed.
Who cannot join
- Intracranial pathology, cerebral palsy, history of severe head injury, significant dysmorphology, or known intracranial lesion.
- History of fainting spells of unknown or undetermined etiology.
- History of head injury resulting in prolonged loss of consciousness.
- History of seizures, diagnosis of epilepsy, or immediate family history of epilepsy.
- Any progressive neurological disorder or signs of intracranial pressure.
- Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure.
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- Metal implants or devices.
- Substance abuse or dependence within the past six months.
- Certain prescription medications that decrease cortical seizure threshold.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Investigations of Neuroplasticity Mechanisms in Autism Spectrum Disorders
The main purpose is to study brain plasticity (the changes that occur in the brain through experience) in individuals with autism spectrum disorder (ASD). Research suggests that during development, the brains of individuals with ASD may change in response to their experiences differently than the brains of typically developing individuals. Investigators want to understand why and how this difference may contribute to the symptoms of ASD.
Read the detailed description
Autism Spectrum Disorders (ASD) are diagnosed clinically, based on key symptoms. As ASD phenotypic variability is large, and symptoms can manifest at different ages and degrees, the clinical diagnosis is challenging. To date, there remains an unmet need for a valid and reliable endophenotype that would facilitate ASD diagnosis early in life, enable efficient study of ASD risk factors, and eventually serve as a useful biomarker to inform the development of effective therapies and assess treatment response in future clinical trials.
As compared with behavioral or neuroimaging methods, transcranial magnetic stimulation (TMS) offers the advantage of providing behaviorally independent results that are largely unaffected by attention or cognitive ability. Therefore, a TMS based endophenotype may be applicable to all individuals across the autism spectrum.
At Boston Children's Hospital, each subject's participation in the study will consist of four visits: two screening visits, and two TMS sessions. At Beth Israel Deaconess Medical Center, each subject's participation will consist of three visits: one screening visit, and two TMS sessions. Each screening visit is expected to last between 2-3 hours, during which participants will first provide informed consent. Participants will then receive a thorough medical examination by a neurologist, and a neuropsychological evaluation (including IQ measures and ASD specific evaluations). If eligible to continue, participants will then come back for two identical TMS visits, that are spaced 1-5 weeks apart. These visits are expected to last between 3-4 hours, and include the TMS measures of brain plasticity.
- Conditions
- Autism Spectrum Disorder, Intellectual Disability
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Autism, ASD, Autistic Disorder, Pervasive Development Disorders, Pervasive Child Development Disorders, Asperger's Syndrome, Transcranial Magnetic Stimulation, TMS, Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability, Autistic Disorder, Child Development Disorders, Pervasive, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Single pulses of TMS as well as continuous theta burst stimulation (cTBS) will be applied to the motor cortex.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder (ASD) | Individuals diagnosed with an Autism Spectrum Disorder (ASD) will receive transcranial magnetic stimulation (TMS) to measure brain plasticity. Receives: Device: Transcranial Magnetic Stimulation | |
| Healthy Control | Typically developing individuals without a history of autism will receive transcranial magnetic stimulation (TMS) to measure brain plasticity. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of baseline TMS-induced measures of human synaptic plasticity
Synaptic plasticity will be measured using the MEPs in response to cTBS. Baseline MEPs will be calculated before cTBS, and at different time points following cTBS up to 120 minutes. The investigators will compare post-cTBS MEPs to the baseline MEPs to calculate the percent change from baseline.
Measured: 120 minutes after cTBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startMay 2015
- Primary completionApr 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Rotenberg, Boston Children's Hospital
- Investigators
- Alexander Rotenberg, MD, PhD, Principal investigator, Boston Children's HospitalAlvaro Pascual-Leone, MD, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836405
- Sponsor's protocol ID
- 00014965
- Other IDs
- 1R01MH100186-01A1
- Status last verified
- Dec 2020
- First submitted
- 13 May 2016
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of Neuroplasticity Mechanisms in Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02836405
- Acronym / sponsor ID
- 00014965
- Conditions
- Autism Spectrum Disorder, Intellectual Disability
- Keywords
- Autism, ASD, Autistic Disorder, Pervasive Development Disorders, Pervasive Child Development Disorders, Asperger's Syndrome, Transcranial Magnetic Stimulation, TMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, National Institute of Mental Health (NIMH)
- Study start
- May 2015
- Primary completion
- Apr 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 19 Jul 2016 (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.
The main purpose is to study brain plasticity (the changes that occur in the brain through experience) in individuals with autism spectrum disorder (ASD). Research suggests that during development, the brains of individuals with ASD may change in response to their experiences differently than the brains of typically developing individuals. Investigators want to understand why and how this difference may contribute to the symptoms of ASD.
Detailed description
Autism Spectrum Disorders (ASD) are diagnosed clinically, based on key symptoms. As ASD phenotypic variability is large, and symptoms can manifest at different ages and degrees, the clinical diagnosis is challenging. To date, there remains an unmet need for a valid and reliable endophenotype that would facilitate ASD diagnosis early in life, enable efficient study of ASD risk factors, and eventually serve as a useful biomarker to inform the development of effective therapies and assess treatment response in future clinical trials.
As compared with behavioral or neuroimaging methods, transcranial magnetic stimulation (TMS) offers the advantage of providing behaviorally independent results that are largely unaffected by attention or cognitive ability. Therefore, a TMS based endophenotype may be applicable to all individuals across the autism spectrum.
At Boston Children's Hospital, each subject's participation in the study will consist of four visits: two screening visits, and two TMS sessions. At Beth Israel Deaconess Medical Center, each subject's participation will consist of three visits: one screening visit, and two TMS sessions. Each screening visit is expected to last between 2-3 hours, during which participants will first provide informed consent. Participants will then receive a thorough medical examination by a neurologist, and a neuropsychological evaluation (including IQ measures and ASD specific evaluations). If eligible to continue, participants will then come back for two identical TMS visits, that are spaced 1-5 weeks apart. These visits are expected to last between 3-4 hours, and include the TMS measures of brain plasticity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder (ASD) | – | Device: Transcranial Magnetic StimulationIndividuals diagnosed with an Autism Spectrum Disorder (ASD) will receive transcranial magnetic stimulation (TMS) to measure brain plasticity. |
| Healthy Control | – | Device: Transcranial Magnetic StimulationTypically developing individuals without a history of autism will receive transcranial magnetic stimulation (TMS) to measure brain plasticity. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults diagnosed with an Autism Spectrum Disorder (ASD), as well as controls.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Intracranial pathology, cerebral palsy, history of severe head injury, significant dysmorphology, or known intracranial lesion.
- History of fainting spells of unknown or undetermined etiology.
- History of head injury resulting in prolonged loss of consciousness.
- History of seizures, diagnosis of epilepsy, or immediate family history of epilepsy.
- Any progressive neurological disorder or signs of intracranial pressure.
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 StimulationSingle pulses of TMS as well as continuous theta burst stimulation (cTBS) will be applied to the motor cortex. | Device | Autism Spectrum Disorder (ASD), Healthy Control |
Primary outcome
Percent of baseline TMS-induced measures of human synaptic plasticity
Time frame: 120 minutes after cTBS
Synaptic plasticity will be measured using the MEPs in response to cTBS. Baseline MEPs will be calculated before cTBS, and at different time points following cTBS up to 120 minutes. The investigators will compare post-cTBS MEPs to the baseline MEPs to calculate the percent change from baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- 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.
Alexander Rotenberg, MD, PhD principal investigator
Boston Children's Hospital
Alvaro Pascual-Leone, MD, PhD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Intellectual Disability, run by Boston Children's Hospital at 2 sites 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 0 inclusion and 10 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: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of baseline TMS-induced measures of human synaptic plasticity (time frame: 120 minutes after cTBS). 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 4 Dec 2020.