Medial Prefrontal Cortex Brain Magnetic Stimulation in Autism

Condition(s) studied

Investigational drug(s) / intervention(s)

TMS: 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 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).

Eligibility

Primary outcome measure(s)

• Social cognitive performance on the "Reading the Mind in the Eyes" Test — 14 days (change from baseline to after 10 working days of intervention)
  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.

Trial sites (1)

More National Taiwan University Hospital trials in Taiwan

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