NCT05735262

Brief Summary

This study aims to evaluate the neuromodulation (i.e., iTBS) effectiveness for treating autism spectrum disorder (ASD) by targeting at the pBFS-guided executive function brain network or social brain network.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

March 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

May 30, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 8, 2023

Last Update Submit

May 26, 2023

Conditions

Autism Spectrum Disorder

Keywords

TMS, fMRI, ASD, personalized

Outcome Measures

Primary Outcomes (1)

  • ADOS-2 SA change

    The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline

    Pre-treatment (baseline), immediately post-treatment

Secondary Outcomes (2)

  • ADOS-2 total score change

    Pre-treatment (baseline), immediately post-treatment

  • CBCL score change

    Pre-treatment (baseline), immediately post-treatment

Other Outcomes (2)

  • SRS-2 score change

    Pre-treatment (baseline), immediately post-treatment

  • RBS-R score change

    Pre-treatment (baseline), immediately post-treatment

Study Arms (4)

DLPFC group

EXPERIMENTAL

Active iTBS will be delivered to the left DLPFC.

Device: active iTBS

DMPFC group

EXPERIMENTAL

Active iTBS will be delivered to the left DMPFC.

Device: active iTBS

Sham to DLPFC group

SHAM COMPARATOR

Sham iTBS will be delivered to left DLPFC.

Device: sham iTBS

Sham to DMPFC group

SHAM COMPARATOR

Sham iTBS will be delivered to left DMPFC.

Device: sham iTBS

Interventions

active iTBSDEVICE

Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.

DLPFC groupDMPFC group
sham iTBSDEVICE

Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.

Sham to DLPFC groupSham to DMPFC group

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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
  • Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
  • Participant's parents or other legal guardians give informed consent

You may not qualify if:

  • Current or history of psychotic disorders, such as schizophrenia, bipolar disorder
  • Severe self-injury or suicidal behavior presented in the last 1 year
  • Severe visual, auditory, or motor disability that interferes with any study procedure
  • Current, history or family history of epilepsy
  • Known severe physical diseases, such as congenital heart defects, traumatic brain injury
  • Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
  • Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months
  • Currently participating in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Rehabilitation Research Center

Beijing, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hesheng Liu, Ph.D.

    Changping Laboratory

    STUDY CHAIR

Central Study Contacts

Qi Liu

CONTACT

010-80726688a0000153@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 8, 2023

First Posted

February 21, 2023

Study Start

March 7, 2023

Primary Completion

March 1, 2024

Study Completion

January 1, 2025

Last Updated

May 30, 2023

Record last verified: 2023-02

Locations

CN(1)