pBFS Guided rTMS Over Cognitive Control Network for ASD

Официальное название

Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial

Обзор

The aim of this trial is to assess the efficacy and safety of precision neuromodulation for alleviating core symptoms in patients with autism spectrum disorder (ASD) who also have intellectual or developmental delay. The neuromodulation will be administered using intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC), guided by personalized Brain Functional Sector (pBFS) technology.

Подробное описание

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impaired social communication and repetitive behaviors. Unfortunately, evidence-based treatments have not proven effective for older individuals with low-functioning ASD, despite their significant need for intensive support. However, emerging evidence suggests that Transcranial Magnetic Stimulation (TMS) has been successful in treating various psychiatric and neurological disorders.

Given the broad cognitive control dysfunction observed in ASD, targeting cognitive control function may offer a promising treatment approach. Leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can precisely locate the cognitive control function region within the left DLPFC, and follow-up at 24-week after initiation of treatment.

In this study, participants who meet the inclusion and exclusion criteria will be randomly assigned to either active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol consists of a 12-week duration, with sessions conducted 5 days per week and 3 sessions iTBS over DLPFC per day. The inter-session interval is set at 30 minutes. Clinical evaluations focusing on ASD core symptoms and related behavioral profiles will be conducted at baseline and after the 12-week treatment period.

Вмешательства

• Устройство active iTBS treatment
  Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Individualized targets will be generated using the pBFS technique.
• Устройство sham iTBS treatment
  Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Sham stimulation will be delivered through a sham coil with the identical appearance as real coil. Individualized targets will be generated using the pBFS technique.

Первичные конечные точки

• ADOS-2 SA CSS score change after treatment [Срок оценки: Pre-treatment (baseline), post-treatment (12-week)]

Вторичные конечные точки (8)

• ADOS-2 SA CSS score change from baseline to follow-up [Срок оценки: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)]
• Response rate in social ability after 12-week iTBS treatment [Срок оценки: Pre-treatment (baseline), post-treatment (12-week)]
• Response rate in social ability at 24-week follow-up [Срок оценки: Pre-treatment (baseline), follow-up (24-week)]
• ADOS-2 total CSS change with treatment [Срок оценки: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)]
• SCQ score change with treatment [Срок оценки: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)]
• CBCL score change with treatment [Срок оценки: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)]
• QoL score change with treatment [Срок оценки: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)]
• AIM score change with treatment [Срок оценки: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)]

Критерии участия

Критерии включения

• 6-30 years old
• Have the diagnosis of autism spectrum disorder
• ADOS-2 score is higher than the ASD cut-offs
• Comorbid with intelligent disorder, IQ/DQ < 70
• Primary environmental language is Chinese
• Participant's parents or other legal guardians give informed consent

Критерии исключения

• Genetic Disorders, such as (e.g., Down syndrome, Fragile X syndrome, Rett syndorme), Current or history of severe ADHD, tourette syndrome, psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
• Severe self-injury or suicidal behavior exhibited within the past year
• Significant visual, auditory, deafness or motor disability that prevent them from following study procedures
• Current or history diagnosis of epilepsy
• Known severe physical diseases, particularly those affecting the brain
• Metal implantation contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
• Respiratory or circulatory conditions increasing sedation risk, such as Apnea syndrome, severe snoring, or other relevant diseases
• All legal guardians are illiterate, unable to read informed documents or complete questionnaires independently
• Received transcranial magnetic stimulation (TMS), transcranial current stimulation (tCS), focused ultrasound (FUS), or other neuromodulation treatment in the last 3 months
• Current participation in other clinical trials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• Fujian Children's Hospital — Фучжоу
• Fujian Maternity and Child Health Hospital — Фучжоу
• Hebei Provincial Mental Health Center — Baoding
• Xi'an TCM Hospital of Encephalopathy — Сиань
• Jining Medical University — Jining
• Linyi Hedong Rehabilitation Hospital — Linyi

Идентификаторы

NCT: NCT06255535 · CPASD05DL_Multicenter

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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