Clinical trial NCT06255535: pBFS Guided rTMS Over Cognitive Control Network for ASD
Official title: Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: intellectual or development delay
personalized
TMS
functional MRI
Lead sponsor: Changping Laboratory
Sponsor class: OTHER
Collaborators: name: Xi'an TCM Hospital of Encephalopathy
name: Linyi Hedong Rehabilitation Hospital
name: Jining Medical University
name: Fujian Maternity and Child Health Hospital
name: Fujian Children's Hospital
name: Hebei Provincial Mental Health Center
First posted: 2024-02-13
Enrollment: 215
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: ADOS-2 SA CSS score change after treatment
timeFrame: Pre-treatment (baseline), post-treatment (12-week)
Secondary outcomes:
measure: ADOS-2 SA CSS score change from baseline to follow-up
timeFrame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
measure: Response rate in social ability after 12-week iTBS treatment
timeFrame: Pre-treatment (baseline), post-treatment (12-week)
measure: Response rate in social ability at 24-week follow-up
timeFrame: Pre-treatment (baseline), follow-up (24-week)
measure: ADOS-2 total CSS change with treatment
timeFrame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
measure: SCQ score change with treatment
timeFrame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
measure: CBCL score change with treatment
timeFrame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
measure: QoL score change with treatment
timeFrame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
measure: AIM score change with treatment
timeFrame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Children's Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Maternity and Child Health Hospital
state: Fujian
city: Baoding
country: China
facility: Hebei Provincial Mental Health Center
state: Hebei
city: Xi'an
country: China
facility: Xi'an TCM Hospital of Encephalopathy
state: Shaanxi
city: Jining
country: China
facility: Jining Medical University
state: Shandong
city: Linyi
country: China
facility: Linyi Hedong Rehabilitation Hospital
state: Shandong
Study officials:
affiliation: Changping Laboratory
name: Hesheng Liu, Ph.D.
role: STUDY_CHAIR
References: