Recruiting

Neurostimulation

Sponsor:

Christiana Care Health Services

Code:

NCT06807684

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

transcranial magnetic stimulation

Study Details

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

Study ID

NCT06807684

Start date

Aug 15, 2024

Status verified date

Feb, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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 measure

  • Exploring neuronal connectivity and oscillatory patterns in the social reciprocity network in ASD [ Time Frame: 9 weeks ]

Central Contacts and Locations

Central contacts

Mitra Assadi, MD

3026233017mitra.assadi@christianacare.org

Ryan Ally, MD

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

Locations

Christiana Care

Recruiting

Newark, Delaware, United States, 19718

Contacts

Mitra Assadi, MD

3026233017mitra.assadi@christianacare.org

More Information

Sponsor

Christiana Care Health Services

Last update posted

Feb 21, 2025

Last verified

Feb, 2025

Keywords

  • Autism spectrum
  • transcranial magnetic stimulation
  • neuronal connectivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Christiana Care Health Services on 2025-02-21.