pBFS Guided rTMS Over Cognitive Control Network for ASD

NCT06255535 | Recruiting

• 1 other identifier: CPASD05DL_Multicenter
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 6

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.

Conditions

Autism Spectrum Disorder

Keywords

intellectual or development delay; personalized; TMS; functional MRI

Outcome Measures

Primary Outcomes (1)

• ADOS-2 SA CSS score change after treatment

  The score changes of ADOS-2 SA CSS (Autism Diagnostic Observation Scale, 2nd edition, social affect domain, calibrated severity score) at 12-week from baseline. Higher scores mean a worse outcome.

  Pre-treatment (baseline), post-treatment (12-week)

Secondary Outcomes (8)

• ADOS-2 SA CSS score change from baseline to follow-up

  Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

• Response rate in social ability after 12-week iTBS treatment

  Pre-treatment (baseline), post-treatment (12-week)

• Response rate in social ability at 24-week follow-up

  Pre-treatment (baseline), follow-up (24-week)

• ADOS-2 total CSS change with treatment

  Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

• SCQ score change with treatment

  Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

Study Arms (2)

active iTBS group

EXPERIMENTAL

active iTBS over DLPFC

Device: active iTBS treatment

Sham group

SHAM COMPARATOR

sham iTBS over DLPFC

Device: sham iTBS treatment

Interventions

active iTBS treatment DEVICE

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.

active iTBS group

sham iTBS treatment DEVICE

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.

Sham group

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changping Laboratory: lead
• Xi'an TCM Hospital of Encephalopathy: collaborator
• Linyi Hedong Rehabilitation Hospital: collaborator
• Jining Medical University: collaborator
• Fujian Maternity and Child Health Hospital: collaborator
• Fujian Children's Hospital: collaborator
• Hebei Provincial Mental Health Center: collaborator

Study Sites (6)

Fujian Children's Hospital

Fuzhou, Fujian, China

RECRUITING

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, China

RECRUITING

Hebei Provincial Mental Health Center

Baoding, Hebei, China

RECRUITING

Xi'an TCM Hospital of Encephalopathy

Xi'an, Shaanxi, China

RECRUITING

Jining Medical University

Jining, Shandong, China

RECRUITING

Linyi Hedong Rehabilitation Hospital

Linyi, Shandong, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Learning Disabilities

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hesheng Liu, Ph.D.

  Changping Laboratory

  STUDY CHAIR

Central Study Contacts

Qi Liu, Ph.D.

CONTACT

010-80726688; liuqi@cpl.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)