Abnormal Connectivity Involving the Social Reciprocity Network in Autism and the Impact of Neurostimulation in Mitigating the Abnormalities
Part of paid clinical trials in Newark, Delaware.
- Sponsor
- Christiana Care Health Services
- Study ID
- NCT06807684
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- transcranial magnetic stimulation — DEVICEThe 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.
Study Details
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.
Key Dates
- Start date
- Aug 15, 2024
- Status verified
- Feb 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Sham Comparator: phase 1During phase I (3 weeks), half of the subjects will receive rTMS, while the other half will receive sham stimulation.
- Active Comparator: phase 2During phase II (3 weeks) all subjects will receive active stimulation.
Primary Outcome Measure
Exploring neuronal connectivity and oscillatory patterns in the social reciprocity network in ASD [ Time Frame: 9 weeks ]
Central Contacts
- Mitra Assadi, MD3026233017
- Ryan Ally, MD302-320-2100
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Christiana Care | Newark | Delaware | 19718 |
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