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rTMS to Improve Motor Function in Autism

Study acronym: (AMBLE Autism)
StatusRecruiting
PhaseNot applicable
Started2024-04-24
View on ClinicalTrials.gov ↗

Amendment history

2026-06-11
minor
Study Status, Study Description, Study Design, Outcome Measures v2
Secondary endpoints2 to 3 entries
Changes in motor function in autistic adults following rTMS.
Primary endpoints2 to 1 entries
Changes in motor function in autistic adults following rTMS.
Study description-59 characters
[...] oronto, each autistic adult's participation will consist of eightsix visits, while each NT adult's participation will include tw [...] plasticity in the motor cortex will be repeated the next day, one week (seventh visit), and four weeks (eighth visit) after the last rTMS session (i.e. 3rd rTMS session).
2025-11-13
minor
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility v1
Eligibility criteria+68 characters
[...] c adults. The intellectual ability will be determined using WAISWASI-II. The ability to provide consent will be determined using cl [...] procedures; Agreement to adhere to Lifestyle Considerations, throughoutthat is: refrain from consumption of alcohol, tobacco, marijuana, or caffeine on the day of study durationvisits. All ASD participants: Will have DSM-5 diagnosis of ASD wit [...] tes); Metal implants or a pace-maker; Prior rTMS treatment; Claustrophobia; In addition, ASD participants will be excluded if they report taking ben [...]
Secondary endpointsdetails revised at 2 of 2 entries
Study description+18 characters
[...] oronto, each autistic adult's participation will consist of nineeight visits, while each NT adult's participation will include tw [...] 3 hours) and a pre- and post-intermittent-TBS (iTBS) session, paired with electroencephalography (EEG), to induce and assess plasticity in the left or right motor [...] andedness) during their second visit (lasting approximately 2.53 hours). Based on the preliminary evidence that rTMS reduces [...] domized, double-blind, sham-controlled design for bilateral 53-session rTMS on the motor cortex. Autistic participants wil [...] 1:1, sex-stratified) to receive either active or sham rTMS (12 [...] [...]
2024-07-05
minor
Original filing
In the current project, investigators have two main goals: i) Testing whether an excessive plasticity, i.e. hyperplasticity in the motor cortex underlies motor function difficulties in autistic adults, and ii) Using repetitive Transcranial Magnetic Stimulation (rTMS) with autistic adults to examine whether resulting reduced hyperplasticity in the motor cortex will be associated with clinical improvements in the motor function.
Trial Details
NCT Number NCT06497920
Lead Sponsor Centre for Addiction and Mental Health
Conditions Autism Spectrum Disorder, Motor Activity
Enrollment 150 participants
Start Date 2024-04-24
Primary Completion 2029-04-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-15