Medial Prefrontal Cortex Brain Magnetic Stimulation in Autism

Sponsor
National Taiwan University Hospital
Study ID
NCT07770451
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

First listed
Aug 18, 2026
Start date
Dec 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TMS pilot group
    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.

Primary Outcome Measure

Social cognitive performance on the "Reading the Mind in the Eyes" Test [ Time Frame: 14 days (change from baseline to after 10 working days of intervention) ]

Central Contacts

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