CompletedNot Applicable

pBFS Guided Neuromodulation Over DMPFC for ASD Treatment: Pilot Study

China22 participantsStarted 2023-03-10

Plain-language summary

This study will evaluate the feasibility and preliminary efficacy of pBFS-guided TMS treatment at DMPFC in autism spectrum disorder comorbid with language delay.

Who can participate

Age range

6 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 6-30 years old * Have the diagnosis of autism spectrum disorder * ADOS-2 score is higher than the ASD cut-offs * Have language development delay (the WISC-4 Verbal Comprehension Index lower than 70) * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Language score change

Timeframe: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment

ADOS-2 SA score change

Timeframe: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment

Trial details

NCT IDNCT07515261

SponsorChangping Laboratory

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-27

View on ClinicalTrials.gov More Autism Spectrum Disorder With Language Delay trials

Who can participate

Age range

6 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.