Clinical trial NCT06807684: Abnormal Connectivity Involving the Social Reciprocity Network in Autism and the Impact of Neurostimulation in Mitigating the Abnormalities
Official title: Discerning the Abnormal Functional Connectivity Involving the Social Reciprocity Network in Autism Spectrum Disorder and the Impact of Transcranial Magnetic Stimulation in Mitigating the Abnormalities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism spectrum
transcranial magnetic stimulation
neuronal connectivity
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 12
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators will recruit ASD cases 13-18 years of age and implementing 18 sessions (3 times/week for 6 weeks) of rTMS or sham stimulation of the bilateral IPL/IFG in a prospective, single blind study design. During phase I (3 weeks), half of the subjects will receive rTMS, while the other half will receive sham stimulation. During phase II (3 weeks) all subjects will receive active 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: Autism spectrum disorder (ASD) encompasses a range of limitations in reciprocal and communicative milestones, leading to significant functional challenges throughout the lifespan. While there is no consensus regarding the neuroanatomical substrate underpinning ASD, there are two major schools of thought: a group of researchers have focused on abnormalities affecting the mirror neurons and other cortical areas involved in social reciprocity, while others have proposed a more widespread alteration in neuronal organization in this condition resulting in abnormal white matter trajectories leading to cortical over or under connectivity. The investigators describe the social reciprocity network: the mirror neurons populated in the inferior frontal gyrus (IFG) and inferior parietal lobule (IPL), plus cortical areas involved in abstract social cognition including the medial prefrontal cortex, temporal-parietal junction and posterior cingulate gyrus. We hypothesize that aberrant connectivity affecting the above neuronal circuitry, "the social reciprocity network" contributes significantly to the core deficits in this condition.

Quantitative electroencephalography (QEEG) coherence and spectral power analysis are reliable measures of functional connectivity and neuronal dynamics. The investigators aim to study the QEEG coherence/spectral power analysis to explore the abnormal neuronal dynamics affecting the social reciprocity network in ASD. The existing literature suggest that noninvasive brain modulation, via Repetitive transcranial magnetic stimulation (rTMS), could potentially ameliorate the aberrant connectivity and the behaviors in ASD by altering neuronal dynamics. The investigator's overarching goal is to explore the neuronal connectivity in the social reciprocity network and to elucidate the mechanism of modulating these connections in improving social cognition in ASD.

Within this design, there are 3 aims:

Aim 1: Exploring the QEEG measures of connectivity and oscillatory patterns in the social reciprocity network in ASD. Hypothesis: abnormal connectivity affecting the social reciprocity network contributes to the core deficits in ASD.

Aim 2: Assessing the effects of rTMS of the bilateral social reciprocity network on the connectivity/spectral analysis as well as social cognition in ASD. Hypothesis: neurostimulation of the social reciprocity network ameliorates social cognition, power densities and the functional connectivity within the network.

Eligibility criteria: Inclusion criteria

1. Fulfilling the DSM-V criteria for ASD and confirmed by CARS2, HF Exclusion criteria

1. Patients with ASD exhibiting significant anxiety or contact avoidance, precluding them from cooperating with the procedure
2. Patients with a known diagnosis of seizures
3. Presence of any metallic implants or devices in the head or neck area
4. Pregnant women

Primary outcomes:
measure: Exploring neuronal connectivity and oscillatory patterns in the social reciprocity network in ASD
timeFrame: 9 weeks
Secondary outcomes:
measure: Assessing the effects of iTBS stimulation of the bilateral social reciprocity network on social cognition in ASD
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care
state: Delaware
Study officials:
References: