Tourette syndrome
Conditions
Interventions
Experimental group:E-CBIT plus Enhanced Follow-up Group:
Participants will receive E-CBIT treatment via an online platform for 2 months, with four sessions per week, each lasting 20 minutes. During th
Control group:E-CBIT Monotherapy Group: Participants will undergo E-CBIT treatment through an online platform for a duration of 2 months, with four 20-minute sessions per week.
Sponsors
Nanjing Brain Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Before any study-related assessments or procedures are conducted, patients and their guardians must fully understand and voluntarily sign the informed consent form (ICF). Patients younger than 8 years old are not required to sign the ICF themselves, but informed consent should still be obtained from their guardians. 2) At the time of signing the ICF, patients must be between 6 and 18 years of age (6 <= age < 18), regardless of gender. 3) Diagnosis of Chronic Tic Disorder (CTD) or Tourette Syndrome (TS) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 4) At screening, the Yale Global Tic Severity Scale (YGTSS) total score is less than 50 (mild to moderate), and the YGTSS-TTS is 14 or higher (or motor or vocal tic score is 10 or higher). 5) Wechsler Intelligence Scale for Children (WISC) score is 70 or above. 6) At least one guardian is able to support and accompany the subject throughout the course of the study. 7) The subject and their guardian have access to a smartphone for at least 30 minutes per day. 8) The subject and their guardian are willing and able to comply with the study schedule, study procedures, and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Presence of other movement disorders such as chorea or Wilson’s disease. 2. Comorbidity with other severe psychiatric or neurodevelopmental disorders that, in the opinion of the investigator, are inappropriate for study participation, such as moderate-to-severe attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), autism spectrum disorder (ASD), substance dependence, major depressive disorder (MDD), suicidal risk, or self-injurious impulses. 3. Currently receiving pharmacological or physical therapies targeting TD. Exceptions: (1) Subjects who have been on stable doses of medications for TD for at least 6 weeks prior to screening (2) Subjects receiving vitamin supplementation (3)Subjects who have completed traditional Chinese medicine interventions such as acupuncture or massage at least 2 weeks prior to screening 4. History of behavioral intervention for TD for 4 weeks or more, including but not limited to CBIT (Comprehensive Behavioral Intervention for Tics), habit reversal training (HRT), or exposure and response prevention (ERP). 5. Severe physical illnesses that would prevent successful participation in this clinical study. 6. Participation in other clinical trials within 3 months prior to screening (except for those who have not received any intervention), or currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in YGTSS-TTS from baseline at Week 8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment adherence at Weeks 4 and 8: completion rate and dropout rate;Improvement rate on the Clinical Global Impression-Improvement (CGI-I) scale (defined as the proportion of subjects rated as 1 or 2 on the CGI-I);Change and percentage change from baseline in YGTSS-TTS at Week 4;Percentage change from baseline in YGTSS-TTS at Week 8;Proportion of subjects with a reduction of =25% in YGTSS total score at Weeks 4 and 8;Change from baseline in Premonitory Urge for Tics Scale (PUTS), Children and Adolescents Gilles de la Tourette Syndrome–Quality of Life Scale (C&A GTS-QoL), and Parent Tic Questionnaire (PTQ) scores at Week 8; | — |
Countries
China
Contacts
Public ContactKe Xiaoyan
Nanjing Brain Hospital
Outcome results
None listed