nctId: NCT06272669 id: HSEARS20220216004 briefTitle: Cumulative and Booster Effects of Multisession Prefrontal tDCS in Adolescents With ASD overallStatus: RECRUITING date: 2022-06-02 date: 2025-09 date: 2025-12 date: 2024-02-22 date: 2024-02-22 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behavior. To date, ASD has no known cure, and the disorder remains a highly disabling condition. Recently, transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique, has shown great promise as a potentially effective and cost-effective tool for reducing the core symptoms in patients with autism, such as anxiety, aggression, impulsivity, and inattention. Although the preliminary findings in patients with ASD are encouraging, it remains to be determined whether this experimental data can translate into benefits in real life. Further studies are needed to determine the factors that can lengthen the therapeutic effects or cognitive benefits of tDCS, and to determine possible risk factors associated with relapse in patients with ASD. Booster sessions of tDCS is an important component of treatment planning and prognosis and may promote better outcomes to control for resurgence of symptoms. This study has three aims. First, the investigators aim to evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD. Second, the investigators aim to better understand the neural mechanisms underlying the neuro-enhancing effects of tDCS in patients with ASD. Third, the investigators aim to assess the effectiveness of booster treatment cycles of tDCS for enhancing cognitive and social functions in individuals with ASD. conditions: Transcranial Direct Current Stimulation conditions: Autistic Spectrum Disorder conditions: Electroencephalography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study comprises 3 phases: Phase 1 will be a randomized controlled trial in which 90 participants will be randomly assigned to receive either active or sham-tDCS combined with computerized executive function training for 10 consecutive working days over 2 weeks period. The other 2 phases will be an open-label, crossover phase, in which for Phase 2, participants in the sham-tDCS group will receive 10-day active tDCS and assessments will be performed before and after the 10-tDCS session. Whereas bimonthly booster tDCS sessions will be provided to all tDCS responders for the first 3 months and monthly booster tDCS in the subsequent 3 months (Total 9 sessions in phase 3), and with assessments performed every month in Phase 3. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Active-tDCS name: Sham-tDCS measure: Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2) measure: Clinical response in tDCS outcome measure: Change in neuropsychological measures - CANTAB® cognitive tests sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hung Hom state: Kowloon zip: Hong Kong country: Hong Kong name: Yvonne Han, PhD role: CONTACT phone: +852 27667578 email: yvonne.han@polyu.edu.hk lat: 22.30715 lon: 114.18532 hasResults: False