CLINICAL TRIAL

Continuous Theta Burst Stimulation for Autism Spectrum Disorder

Recruiting · < 65 · All Sexes · Bethesda, MD

Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder

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About the trial for Autism Spectrum Disorder

Eligible Conditions
Autistic Disorder · Autism Spectrum Disorder · Child Development Disorders, Pervasive

Treatment Groups

This trial involves 4 different treatments. Continuous Theta Burst Stimulation is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Continuous Theta Burst Stimulation
DEVICE
Experimental Group 2
Continuous Theta Burst Stimulation
DEVICE
Control Group 3
Continuous Theta Burst Stimulation
DEVICE
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Eligibility

This trial is for patients born any sex aged 65 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Pilot Phase
You are able to provide informed consent. show original
Age: 18-25 years
Must meet the definition of Healthy Control having completed the screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers or under protocol 17-M-0181, Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies .
Main Study Phase
Ability to provide informed assent and parent consent
Age: 14-17 years
You have a community diagnosis of ASD based on DSM-IV or DSM-5 criteria. show original
Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) show original
You are right-handed.\n show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: immediately pre and post rTMS
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately pre and post rTMS
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: immediately pre and post rTMS.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Continuous Theta Burst Stimulation will improve 3 primary outcomes and 3 secondary outcomes in patients with Autism Spectrum Disorder. Measurement will happen over the course of immediately pre and post rTMS.

DTI
IMMEDIATELY PRE AND POST RTMS
Diffusion tensor derived parameters in the auditory radiations and arcuate fasciculus.
IMMEDIATELY PRE AND POST RTMS
fcMRI
IMMEDIATELY PRE AND POST RTMS
BOLD correlations across pre-defined ROIs.
IMMEDIATELY PRE AND POST RTMS
MEG
IMMEDIATELY PRE AND POST RTMS
Inter-trial gamma-band coherence (ITC) and resting state alpha to gamma phase-amplitude coupling.
IMMEDIATELY PRE AND POST RTMS
Neuropsychological Assessments
BASELINE
SRS-2, CELF-5, EVT, PPVT, ADOS-2, ADI-R, VABS-III, WASI-II.
BASELINE
Behavioral Measures
BASELINE
SRS-2, CELF-5, EVT, PPVT, ADOS-2, ADI-R, VABS-III, WASI-II.
BASELINE
MRS
IMMEDIATELY PRE AND POST RTMS
GABA+/Cr concentrations in the left pSTC
IMMEDIATELY PRE AND POST RTMS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can autism spectrum disorder be cured?

There is no convincing scientific evidence that the core symptoms of ASD can be cured with non-invasive brain therapy. A large-scale, multicenter, and controlled clinical trial is currently funded to test how effective this brain stimulation approach can be in managing comorbid ASD symptoms in patients who are already taking pharmaceuticals to treat their ASD symptoms. This randomized, double-blind, controlled trial of 24 to 49 participants (in their early-30s with ASD) who received a 3-week 'intervention' or 'control' period on an as-needed (i.e.'real') basis will be followed for 2 years. The intervention is currently being conducted in Boston, Massachusetts and is being led by Dr. John H.

Anonymous Patient Answer

How many people get autism spectrum disorder a year in the United States?

Data from a recent study of this study reveal that 1 in 17 children with a reported ASD diagnosis met the DSM-IV criteria for ASD, which suggests that ASDs are underdiagnosed in the United States. A larger, prospective study of diagnostic rates of ASD must be conducted to clarify these findings.

Anonymous Patient Answer

What causes autism spectrum disorder?

Results from a recent clinical trial helps to identify risk factors which may be involved in the pathogenesis of ASD. Such factors may be the focus of interventions intended to reduce the risk of ASD in subsequent generations.

Anonymous Patient Answer

What are common treatments for autism spectrum disorder?

Cognitive behavioral therapy and special education have been shown to improve the symptoms and quality of life of individuals with autism spectrum disorder. Attention-deficit hyperactivity disorder hyperactivity and oppositional defiant disorder appear to benefit with medication.

Anonymous Patient Answer

What is autism spectrum disorder?

Autism spectrum disorder (ASD) is thought to be caused by genetic factors. It is a disorder of the communication, cognition, and social interaction among individuals. It is a brain disorder that impacts on functioning throughout life. It is thought to affect between 1 in 200 and 1 in 300 people in the USA.\n

Anonymous Patient Answer

What are the signs of autism spectrum disorder?

Signs of ASD may include delay or absence of development, unusual social interaction and communication, or repetitive behavior. Other signs include problems with sensory processing and motor functioning, and in autism may include developmental disorder of coordination (DDC) and other behavioral and cognitive impairments.\n

Anonymous Patient Answer

Have there been other clinical trials involving continuous theta burst stimulation?

The present study is the first to demonstrate that cTBS leads to robust improvements in ASD symptoms. Additional work is required to confirm our finding and assess the effects of cTBS in patients with ASD.

Anonymous Patient Answer

Is continuous theta burst stimulation safe for people?

Theoretically, the treatment is safe. However, the present study was performed at the time of a sudden, unexpected move from two weeks of regular stimulation (that was safe) to a new, potentially dangerous, regimen. It was reported that this trial was originally planned to last for 10 weeks but had been canceled after only two. It is therefore possible that some safety issues may remain when the treatment is continued, because it is possible for subjects to move away from, or disengage from, the electrical current when the frequency is increased from 25 to 100 Hz, or from 2 to 7 Hz. This does not affect the overall number of days that would have to have been spent under continuous TBS.

Anonymous Patient Answer

What does continuous theta burst stimulation usually treat?

The effects of cTBS can't be explained purely by the effects of the anodal electrode stimulation. One explanation for the effectiveness of cTBS is given by the "nocebo effect" of TBS. This finding emphasizes the need for further research in this promising and emerging therapy for neurological conditions.

Anonymous Patient Answer

What is the primary cause of autism spectrum disorder?

Autistic symptoms in the child are often a result of a complex interaction between genetic predispositions and environmental factors. Most children with autism have at least one other medical problem that may be the cause of most of the core symptoms of the syndrome.

Anonymous Patient Answer

What is the latest research for autism spectrum disorder?

The following are the new findings that have been published between 2003 and 2006 that may relate to ASD:\n- New evidence indicates early brain dysfunction in children with ASD.\n- Several genetic variants associated with ASD are associated with alterations in the central nervous system (CNS), including the cerebellum.\n- Several genes are found for ASD by sequencing methods, and can be found in one database. Findings from a recent study indicate that there are more genes or mutations than previously thought accountable for this disorder.\n- A study involving multiple participants indicates that the onset of ASD may be linked to genetic predispositions and possibly a single, common environmental factor.

Anonymous Patient Answer

Has continuous theta burst stimulation proven to be more effective than a placebo?

Contrary to expectations, the present exploratory study of children with autism and epilepsy did not provide evidence for a stronger TBS effect on autism than on epilepsy in this pediatric population. A more thorough investigation in patients with more severe symptoms is warranted.

Anonymous Patient Answer
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