NCT07910305Toborzás még nem indult
Transcranial Magnetic Stimulation (TMS) for Autism Spectrum Disorder
Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation (rTMS) for Autism Spectrum Disorder: A Novel Treatment Approach
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 3.
Rövid összefoglaló (regiszter, angolul)
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by persistent difficulties in social communication and interaction, as well as restricted and repetitive patterns of behavior. Emerging evidence suggests that the cerebellum plays an important role in social cognition and behavioral regulation, and abnormalities in cerebellar structure and function may contribute to the pathophysiology of ASD.Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that may modulate neural activity and functional connectivity within brain networks associated with ASD. However, the therapeutic effects of individualized cerebellar-targeted rTMS in children and adolescents with ASD remain unclear. This study aims to investigate the efficacy and safety of individualized cerebellar-targeted rTMS guided by magnetic resonance imaging (MRI) in children and adolescents with ASD. Additionally, the study will explore the effects of rTMS on brain structure and functional connectivity. This is a multicenter, single-arm, exploratory interventional study involving 120 participants aged 6 to 18 years who meet the DSM-5 diagnostic criteria for ASD. Participants will receive individualized cerebellar-targeted intermittent theta-burst stimulation (iTBS) guided by MRI-based neuronavigation for two consecutive weeks.Clinical assessments and MRI examinations will be conducted at baseline, week 2, and week 12. Clinical outcomes will be evaluated using the Social Responsiveness Scale (SRS), Repetitive Behavior Scale-Revised (RBS-R), and Strengths and Difficulties Questionnaire (SDQ). Adverse events associated with rTMS will also be monitored. Peripheral blood samples will be collected once at baseline for genetic testing and genotyping to characterize genetic variation among participants. The findings of this study may provide preliminary evidence regarding the feasibility, safety, and potential therapeutic effects of individualized cerebellar-targeted rTMS in children and adolescents with ASD.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 120 (tervezett)
- Első benyújtás
- 2026. okt. 26.
- Kezdés
- 2026. nov. 1.
- Elsődleges befejezés
- 2028. dec. 1.
- Fő szponzor
- Sir Run Run Shaw Hospital
- Betegségek
- Autizmus spektrumzavar
- NCT-szám
- NCT07910305
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 120
- 2026. nov. 1. és az elsődleges befejezés (2028. dec. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Presence of severe medical conditions or physical disorders, including but not limited to congenital heart disease, thyroid disorders, hepatic or renal dysfunction, and visual or hearing impairments.
- Presence of severe neurological disorders, a documented family history of such disorders, or potential neurological risks, including but not limited to traumatic brain injury, encephalitis, epilepsy, febrile seizures, birth-related injuries, or abnormal electroencephalographic (EEG) findings.
- Presence of confirmed or suspected genetic disorders, such as trisomy 21 (Down syndrome) or fragile X syndrome.
- Diagnosis of other developmental disorders, such as isolated intellectual disability, isolated language developmental disorder, or selective mutism.
- Diagnosis of other severe psychiatric disorders, such as schizophrenia or bipolar disorder.
Kiket keres a vizsgálat
- Aged 6-18 years.
- Meet the diagnostic criteria for autism spectrum disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Have a Childhood Autism Rating Scale (CARS) score \>30.
- Voluntarily agree to participate in the study and provide written informed consent. For participants who are unable to read or sign the informed consent form due to a lack of legal capacity or other reasons, or for participants who are minors, informed consent must be obtained from their legally authorized representatives or legal guardians.
Életkor a regiszterben: 6 év – 18 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Hangzhou | Kína | Ismeretlen állapot |
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