Medial Prefrontal Cortex Brain Magnetic Stimulation in Autism

NCT07770451 | Not Yet Recruiting

• 1 other identifier: 202508055DINA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Autism Spectrum Disorder

Keywords

autism spectrum disorder; asd; Deep Transcranial Magnetic Stimulation; dTMS; Medial Prefrontal Cortex; mPFC; brain stimulation; neuromodulation

Outcome Measures

Primary Outcomes (1)

• Social cognitive performance on the "Reading the Mind in the Eyes" Test

  The Reading the Mind in the Eyes Test (RMET; Baron-Cohen et al., 2001) will be used to assess recognition of emotional and mental states from facial cues. First, participants will complete the Basic Emotion Recognition Task, identifying six basic emotions-happiness, sadness, anger, fear, disgust, and surprise-from whole-face photographs using a two-choice format. They will then complete the standard RMET, which contains 36 photographs of the eye region depicting complex mental states. For each image, participants select the most appropriate of four descriptors. To examine possible cultural differences, the Taiwanese RMET (TW-RMET) is administered alongside the original UK version. The TW-RMET includes 43 culturally adapted items and has been validated in Taiwanese populations (Li et al., 2022). Higher scores indicates a stronger ability to accurately interpret emotional and mental cues from facial expressions.

  14 days (change from baseline to after 10 working days of intervention)

Secondary Outcomes (12)

• The Social Responsiveness Scale (SRS)

  14 days (change from baseline to after 10 working days of intervention)

• The Autism-Spectrum Quotient (AQ)

  14 days (change from baseline to after 10 working days of intervention)

• The Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R)

  14 days (change from baseline to after 10 working days of intervention)

• The Empathy Quotient (EQ)

  14 days (change from baseline to after 10 working days of intervention)

• Adolescent/Adult Sensory Profile (AASP)

  14 days (change from baseline to after 10 working days of intervention)

Other Outcomes (1)

• Stratification biomarker: Resting-state EEG: aperiodic exponent (1/f)

  30 mintues (change between baseline and immediately after initial 20-minute dTMS treatment)

Study Arms (1)

TMS pilot group

EXPERIMENTAL

Each participant will receive one session of magnetic stimulation and undergo resting-state electroencephalography (EEG) before and after stimulation. Subsequently, they will receive magnetic stimulation once daily for 10 days, for a total of 10 sessions. On the day of the tenth stimulation session or within three days afterward, participants will undergo post-treatment assessment and brain MRI.

Device: TMS

Interventions

TMS DEVICE

The TMS device (Brainsway Deep TMS system with an H1 coil device, Brainsway Ltd, Israel) emits brief, noninvasive electromagnetic pulses through the skull, inducing an electrical current in a specific cortical region to affect neuronal function. Subjects will receive 10 once-daily high-frequency repetitive TMS sessions on 10 consecutive work days. To stimulate the mPFC, the H1 coil helmet will be placed symmetrically bilaterally and with its zero mark 3 cm above the nasion on the sagittal rule. The stimulation parameters follow the standard protocol cleared by the USFDA. Each session consists of 55 trains of 2-sec 18-Hz stimulation, given every 20 sec (2-sec on and 18-second off, inter-train interval 20 sec), and the stimulation intensity is 120% resting motor threshold (rMT). As such 1980 pulses will be given in around 20 minutes each session. The rMT is the minimal stimulation intensity that can induce observable muscle contraction in at least 5 out of 10 consecutive stimulations.

TMS pilot group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Psychiatry, National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Yi-Ling Chien, MD, PhD

CONTACT

866+223123456; ntuh.peers@gmail.com

Yi-Ting Lin, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 18, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)