NCT06031948

Brief Summary

This randomized controlled trial aims to evaluate the efficacy and safeness of the pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism spectrum disorder (ASD).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

September 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

September 4, 2023

Last Update Submit

September 4, 2023

Conditions

Autism Spectrum Disorder

Keywords

TMSASDfMRIpersonalized medicine

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. Higher scores mean a worse outcome.

    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 (3)

  • SCQ score change

    Pre-treatment (baseline), immediately post-treatment

  • 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 the left DLPFC.

Device: sham iTBS

Sham to DMPFC group

SHAM COMPARATOR

Sham iTBS will be delivered to the 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 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 group

Eligibility Criteria

Age30 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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, schizoaffective disorder, 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 defect, 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

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, Ph.D.

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

September 4, 2023

First Posted

September 11, 2023

Study Start

October 1, 2023

Primary Completion

August 1, 2024

Study Completion

January 1, 2025

Last Updated

September 11, 2023

Record last verified: 2023-09