NCT06807684 · Christiana Care Health Services
Abnormal Connectivity Involving the Social Reciprocity Network in Autism and the Impact of Neurostimulation in Mitigating the Abnormalities
What this study is about
There is no consensus regarding the neurological substrate underpinning ASD. The investigators describe the novel concept of "social reciprocity network" and hypothesize that aberrant connectivity/oscillatory patterns affecting this network contribute to the core deficits in ASD.
View original scientific description
There is no consensus regarding the neurological substrate underpinning ASD. The investigators describe the novel concept of "social reciprocity network" and hypothesize that aberrant connectivity/oscillatory patterns affecting this network contribute to the core deficits in ASD. The overarching goal of this trial is to explore abnormalities involving the neuronal connectivity and oscillatory patterns within the social reciprocity network and to elucidate the role of modulating this network via rTMS in improving the above measures and social cognition in ASD. Quantitative electroencephalography (QEEG) coherence and spectral power analysis are reliable measures of neuronal connectivity and dynamics. The investigators aim to study the QEEG coherence/spectral power analysis to explore the neuronal dynamics affecting the social reciprocity network in ASD.
Interventions
DEVICE
transcranial magnetic stimulation
The investigators will deliver a type of high frequency rTMS known as intermittent theta burst stimulation (iTBS), 2400 stimulations per session, equally divided between the bilateral IPL and IFG.
Primary outcome measures
Exploring neuronal connectivity and oscillatory patterns in the social reciprocity network in ASD
Time frame: 9 weeks
Abnormal connectivity affecting the social reciprocity network contributes to the core deficits in ASD. The investigators will record an electroencephalogram (EEG) at baseline and after completing treatments with transcranial magnetic stimulation. The EEG data will be subjected to mathematical analysis in order to calculate measures of EEG coherence, functional connectivity and oscillatory patterns within the social reciprocity network. These numerical values will be used to discern: 1. presence of a consistent pattern across the social reciprocity network at baseline for measurements of neuronal connectivity as well as the oscillatory patterns including alpha, beta, gamma, theta and mu rhythms 2. improvement of the above neuronal connectivity and oscillatory patterns after the transcranial magnetic intervention
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 1\. Fulfilling the DSM-V criteria for ASD and confirmed by CARS2, HF
Exclusion criteria
- Patients with ASD exhibiting significant anxiety or contact avoidance, precluding them from cooperating with the procedure
- Patients with a known diagnosis of seizures
- Presence of any metallic implants or devices in the head or neck area
- Pregnant women
Where
- Newark, Delaware
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced Feb 21, 2025 · Source of record for eligibility and locations