pBFS Guided Neuromodulation Over DMPFC for ASD Treatment: Pilot Study (NCT07515261) | Clinical Trial Compass
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 range6 Years – 30 Years
SexALL
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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
What they're measuring
1
Language score change
Timeframe: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
2
ADOS-2 SA score change
Timeframe: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment