Status:
WITHDRAWN
Efficacy of Biofeedback in the Treatment of Tic Disorder
Lead Sponsor:
Children's Hospital of Fudan University
Collaborating Sponsors:
Shanghai Normal University
Conditions:
Tic Disorders
Eligibility:
All Genders
8-16 years
Phase:
PHASE4
Brief Summary
To investigate the efficacy of EEG biofeedback and drug therapy in the treatment of tic disorders
Detailed Description
This study intends to investigate the efficacy of EEG biofeedback and drug therapy on clinical symptoms, cognitive flexibility and quality of life in chronic tic disorder and Tourette syndrome through...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders(Fifth Edition,DSM-5) for chronic tic disorder or Tourette syndrome（TS）;
- Ethnic group is Han nationality;
- Aged 8 \~ 16 years old;
- otal IQ of Wechsler Intelligence Scale for Children ≥ 80 points for subjects;
- Symptom severity score in Yale Global Severity Scale (YGTSS), TS patients \> 13, CTD \> 9;
- Did not receive any drug (including traditional Chinese medicine) treatment 4 weeks before enrollment;
- Obtain written informed consent from children and guardians
Exclusion
- Epilepsy, cardiovascular disease
- Patients with schizophrenia, mental retardation, autism spectrum disorder, bipolar disorder and major depression who meet the DSM-5 diagnostic criteria;
- Receiving systematic traditional Chinese medicine treatment one month before enrollment or currently;
- Receiving systematic psychotherapy one month before enrollment or currently;
- Receive systematic physical therapy one month before enrollment or currently
- Those who cannot follow the doctor's advice or refuse to cooperate;
- Those with obvious abnormal laboratory test results (AST or ALT ≥ 2 times of the upper limit of normal value; bun ≥ 1.5 times of the upper limit of normal value; Cr ≥ 1.2 times of the upper limit of normal value);
- Prolongation of QTc interval (QTc ≥ 450 ms in men or ≥ 470 MS in women);
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05361993
Start Date
June 1 2024
End Date
December 31 2024
Last Update
January 20 2025
Active Locations (1)
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1
Children's hospital of Fundan University
Shanghai, Shanghai Municipality, China, 201102