Medial Prefrontal Cortex Brain Magnetic Stimulation in Autism | NCT07770451 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 18, 2026

Medial Prefrontal Cortex Brain Magnetic Stimulation in Autism

The Efficacy and Brain Mechanism of Deep Transcranial Magnetic Stimulation in Autism: A Pilot Study Targeting Medial Prefrontal Cortex

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07770451
Lead Sponsor: National Taiwan University HospitalOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 20Estimated
Last Update Posted: Aug 18, 2026Actual
Start Date: Dec 1, 2026Estimated
Primary Completion Date: Dec 31, 2028Estimated
Completion Date: Dec 31, 2028Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: The Efficacy and Brain Mechanism of Deep Transcranial Magnetic Stimulation in Autism: A Pilot Study Targeting Medial Prefrontal Cortex
Brief Summary: Despite decades of research, no definitive, effective biological treatments exist for core symptoms of Autism Spectrum Disorder (ASD). Emerging evidence suggests that conventional Transcranial Magnetic Stimulation (TMS) targeting the dorsolateral prefrontal cortex or posterior superior temporal sulcus may reduce repetitive behaviors, but its efficacy on social communication remains inconsistent.

Deep Transcranial Magnetic Stimulation (dTMS) allows for the stimulation of deeper brain structures. Deep social brain networks, such as the medial prefrontal cortex (mPFC), play a critical role in social cognition and mentalizing processes. Targeting the mPFC with dTMS holds potential for improving core impairments in social cognition among individuals with ASD. This pilot study aims to evaluate the efficacy of dTMS on social cognition, mPFC-related functional connectivity, and clinical symptoms (autism severity, stereotyped behaviors, sensory symptoms, and emotion regulation).

Conditions

The medical conditions and diseases this study investigates.

Autism Spectrum Disorder

Interventions

The treatments and procedures being evaluated in this study.

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Having a diagnosis of autism spectrum disorder based on DSM-5-TR diagnosis criteria

Aged 18-45 years old

No change of medications in the past three months

Exclusion Criteria:

Comorbidity of schizophrenia, substance use disorder,

Had major medical diseases (e.g., malignancy, severe cardiac, hepatic, renal diseases, or active CNS or systemic infection) or major neurological disease (e.g., uncontrolled epilepsy, brain tumors or hemangioma, severe head trauma)

Contraindications of MRI or TMS procedure: Ferromagnetic material in the skull, head, and neck; claustrophobia; had received neurosurgery, etc.

Receiving electroconvulsive therapy or TMS in the past three months

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Yi-Ling Chien, MD, PhDContact

ntuh.peers@gmail.com866+223123456 ext. 262380

Locations

Where the study is run and whether each site is currently recruiting.

Department of Psychiatry, National Taiwan University Hospital

Taipei, Taiwan

Collaborators

The organizations and people involved in this study.

Lead Sponsor: National Taiwan University HospitalOTHER

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Other registered studies that closely resemble this one.

Detailed Description

Conventional repetitive Transcranial Magnetic Stimulation (rTMS) and intermittent Theta Burst Stimulation (iTBS) targeting regions such as the dorsolateral prefrontal cortex (DLPFC) or posterior superior temporal sulcus (pSTS) have shown moderate efficacy in reducing repetitive behaviors and irritability in Autism Spectrum Disorder (ASD). However, their therapeutic effects on core social communication deficits remain inconsistent (~30% response rate in pSTS studies). A key physical limitation of standard TMS/TBS figure-of-eight coils is their shallow stimulation depth (0.7 to 1.1 cm), which restricts their ability to directly reach deeper cortical structures within the "social brain" network.Deep Transcranial Magnetic Stimulation (dTMS) utilizes specialized coil geometry (such as H-coils) to deliver magnetic fields to deeper brain structures (1.8 to 3.5 cm) over larger volumes. The medial prefrontal cortex (mPFC) is a central hub of the social brain network, playing a vital role in social cognition, emotion processing, and mentalization. Preliminary evidence suggests that targeting the mPFC/dorsomedial PFC with dTMS can improve emotion recognition, reduce self-oriented social anxiety, and alleviate core autistic symptoms in high-functioning adults. This pilot study aims to evaluate the safety, clinical efficacy, neural mechanism, and predictive biomarkers of mPFC-targeted dTMS in autistic adults.Study Objectives & Research QuestionsThis single-arm/pilot clinical trial is designed to address the following specific research questions and objectives:Safety and Tolerability: Evaluate the overall safety, side-effect profile, and tolerability of high-frequency dTMS targeting the mPFC in adults with ASD.

Clinical Efficacy:

Assess whether 10 sessions of high-frequency dTMS lead to significant improvements in core ASD domains, with emotion recognition (social cognition) as the primary outcome measure. Secondary outcomes include overall autism severity, repetitive/stereotyped behaviors, sensory processing abnormalities, and emotional regulation.Neural Connectivity (fMRI): Utilize functional Magnetic Resonance Imaging (fMRI) to evaluate post-treatment changes in functional connectivity between the mPFC and other key nodes of the social brain network (e.g., amygdala, orbitofrontal cortex, superior temporal sulcus, anterior cingulate cortex, and temporoparietal junction). Predictive Biomarkers (EEG E/I Balance): Investigate whether acute electroencephalography (EEG) shifts in the excitation/inhibition (E/I) balance-estimated via changes in the aperiodic exponent after a single initial dTMS session-can serve as a neurophysiological biomarker to predict final clinical and neural connectivity responses.

All participants will receive the same deep rTMS intervention. Following treatment, participants will grouped into high response and low response subgroups based on changes of their aperiodic exponent before and after the single-session dTMS for further analysis.