pBFS Guided rTMS Over Cognitive Control Network for ASD

Autism Spectrum Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06255535
• Other study ID #: CPASD05DL_Multicenter
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: April 2024
• Source: Changping Laboratory
• Contact: Qi Liu, Ph.D.
• Phone: 010-80726688
• Email: liuqi[@]cpl.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Changping Laboratory	Fujian Children's Hospital, Fujian Maternity and Child Health Hospital, Jining Medical University, Linyi Hedong Rehabilitation Hospital, Xi'an TCM Hospital of Encephalopathy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate after 12 weeks treatment	Treatment response is defined as improvement, i.e., scores decreased, in the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2). For ADOS-2 SA, higher scores means more severe symptom.	Pre-treatment (baseline), immediately post-treatment
Secondary	ADOS-2 SA score change	The score changes of ADOS-2 SA from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), immediately post-treatment
Secondary	SCQ score change	SCQ score change from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), immediately post-treatment
Secondary	ADOS-2 total score change	The ADOS-2 total score change from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), immediately post-treatment
Secondary	CBCL score change	Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.	Pre-treatment (baseline), immediately post-treatment