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Precision TMS Treatment Guided by Personalized Brain Functional Sectors (pBFS) for ASD

Sponsor
Changping Laboratory (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05890846
Collaborator
Xuanwu Hospital, Beijing (Other)
150
Enrollment
4
Arms
23.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: active iTBS
  • Device: active iTBS
  • Device: sham iTBS
  • Device: sham iTBS
 N/A

Detailed Description

Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors. Using the personalized Brain Functional Sectors (pBFS) technique, we could precisely identify individualized brain areas underlying social communication and executive function based on the resting-state functional MRI data. Two tailored TMS intervention targets will be selected for each participant by a blinded researcher. One is the dorsal medial prefrontal cortex (DMPFC) target within the social function network, and the other one is the dorsal lateral prefrontal cortex (DLPFC) target within the executive function network.

The participants will be equally randomized to the following four groups, active iTBS to the left DMPFC or the left DLPFC, and sham iTBS to either the left DMPFC or left DLPFC at a ratio of 2:2:1:1. The two sham groups will be combined as one control group in later analyses. Each participant will receive 5 days of treatment per week for 8 weeks. Functional MRI data under sedation will be collected pre-and post-treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Personalized Brain Functional Sectors (pBFS) Guided Transcranial Magnetic Stimulation (TMS) Treatment for Autism Spectrum Disorder (ASD): a Single-center, Sham-controlled, Double-blinded, Randomized Clinical Trial Study
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
May 20, 2024
Anticipated Study Completion Date :
May 20, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: DMPFC group

Active iTBS will be delivered to the left DMPFC.

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

Active iTBS will be delivered to the left DLPFC.

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

Sham iTBS will be delivered to the left DMPFC.

Device: sham iTBS
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 Comparator: Sham to DLPFC group

Sham iTBS will be delivered to the left DLPFC.

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

Outcome Measures

Primary Outcome Measures

  1. ADOS-2 SA change [Pre-treatment (baseline), immediately post-treatment]

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

Secondary Outcome Measures

  1. ADOS-2 total score change [Pre-treatment (baseline), immediately post-treatment]

    The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline

  2. CBCL score change [Pre-treatment (baseline), immediately post-treatment]

    Score change of the child behavior checklist (CBCL) from baseline

Other Outcome Measures

  1. SRS-2 score change [Pre-treatment (baseline), immediately post-treatment]

    Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline

  2. SCQ score change [Pre-treatment (baseline), immediately post-treatment]

    Score change of the Social Communication Questionnaire (SCQ) from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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 parents or other legal guardians give informed consent

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Changping Laboratory
  • Xuanwu Hospital, Beijing

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changping Laboratory
ClinicalTrials.gov Identifier:
NCT05890846
Other Study ID Numbers:
  • CPASD2023XW150
First Posted:
Jun 6, 2023
Last Update Posted:
Jun 6, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Changping Laboratory
TMS, personalized, ASD, fMRI
Additional relevant MeSH terms:
Autism Spectrum Disorder

Study Results

No Results Posted as of Jun 6, 2023