NCT05890846

Brief Summary

This study will evaluate the efficacy and safety of pBFS-guided TMS treatment for the core symptom in autism spectrum disorder children, adolescents and young adults.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

May 26, 2023

Last Update Submit

April 1, 2024

Conditions

Autism Spectrum Disorder

Keywords

TMSpersonalized medicineASDfMRI

Outcome Measures

Primary Outcomes (1)

  • Response rate after 12 weeks treatment

    Treatment response is defined as improvement, i.e., scores decreased, in both the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom.

    Pre-treatment (baseline), after 12-weeks treatment

Secondary Outcomes (6)

  • Response rate after 8 weeks treatment

    Pre-treatment (baseline), after 8-weeks treatment

  • ADOS-2 SA score change

    Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment

  • SCQ score change

    Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment

  • ADOS-2 total score change

    Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment

  • CBCL score change

    Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment

  • +1 more secondary outcomes

Study Arms (2)

DLPFC group

EXPERIMENTAL

Active iTBS will be delivered to the cognitive control network at left DLPFC.

Device: active iTBSBehavioral: traditional 1on1 course

Sham group

SHAM COMPARATOR

Sham iTBS will be delivered to the cognitive control network at left DLPFC.

Device: sham iTBSBehavioral: traditional 1on1 course

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 12 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 12 weeks.

Sham group
traditional 1on1 courseBEHAVIORAL

Between every two iTBS sessions, the participant will receive a personalized 30-minutes one-on-one behavioral course, 2 courses per day, 5 days per week for 12 weeks.

DLPFC groupSham group

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Nearest age 6-30 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 parent or other legal guardian 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 one year
  • Severe visual, auditory, or motor disability that interferes with any study procedure
  • Current or history of seizure
  • 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

Study Sites (2)

Henan Provincial People's Hospital

Zhengzhou, Henan, China

RECRUITING

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, 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

May 26, 2023

First Posted

June 6, 2023

Study Start

June 25, 2022

Primary Completion

September 20, 2024

Study Completion

September 20, 2025

Last Updated

April 2, 2024

Record last verified: 2024-04

Locations

CN(2)