Abnormal Connectivity Involving the Social Reciprocity Network in Autism and the Impact of Neurostimulation in Mitigating the Abnormalities

NCT06807684 | Recruiting FDA Device

• 1 other identifier: DDD 605632
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism spectrum; transcranial magnetic stimulation; neuronal connectivity

Outcome Measures

Primary Outcomes (1)

• Exploring neuronal connectivity and oscillatory patterns in the social reciprocity network in ASD

  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

  9 weeks

Secondary Outcomes (1)

• Assessing the effects of iTBS stimulation of the bilateral social reciprocity network on social cognition in ASD

  9 weeks

Study Arms (2)

phase 1

SHAM COMPARATOR

During phase I (3 weeks), half of the subjects will receive rTMS, while the other half will receive sham stimulation.

Device: transcranial magnetic stimulation

phase 2

ACTIVE COMPARATOR

During phase II (3 weeks) all subjects will receive active stimulation.

Device: transcranial magnetic stimulation

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.

phase 1; phase 2

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care

Newark, Delaware, 19718, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Mitra Assadi, MD

CONTACT

3026233017; mitra.assadi@christianacare.org

Ryan Ally, MD

CONTACT

302-320-2100; ryan.ally@christianacare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Professor of Neurology

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: February 4, 2025
• Study Start: August 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: January thru Dec 2025

Locations

US (1)