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 — DEVICE
    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.

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 1
    During phase I (3 weeks), half of the subjects will receive rTMS, while the other half will receive sham stimulation.
  • Active Comparator: phase 2
    During 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

Locations (1)

FacilityCityStateZIPSite coordinators
Christiana CareNewarkDelaware19718
Mitra Assadi, MD
3026233017

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