pBFS Guided rTMS Over Cognitive Control Network for ASD

April 1, 2024 updated by: Changping Laboratory

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active iTBS group
active iTBS over DLPFC
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 Comparator: Sham group
sham iTBS over DLPFC
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate after 12 weeks treatment
Time Frame: Pre-treatment (baseline), immediately post-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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CBCL score change
Time Frame: Pre-treatment (baseline), immediately post-treatment
Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), immediately post-treatment
ADOS-2 SA score change
Time Frame: Pre-treatment (baseline), immediately post-treatment
The score changes of ADOS-2 SA from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), immediately post-treatment
SCQ score change
Time Frame: Pre-treatment (baseline), immediately post-treatment
SCQ score change from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), immediately post-treatment
ADOS-2 total score change
Time Frame: Pre-treatment (baseline), immediately post-treatment
The ADOS-2 total score change from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), immediately post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changping Laboratory

Collaborators

Fujian Maternity and Child Health Hospital
Jining Medical University
Xi'an TCM Hospital of Encephalopathy
Linyi Hedong Rehabilitation Hospital
Fujian Children's Hospital

Investigators

  • Study Chair: Hesheng Liu, Ph.D., Changping Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPASD05DL_Multicenter

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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