Efficacy of Biofeedback in the Treatment of Tic Disorder

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy of EEG biofeedback and drug therapy in the treatment of tic disorders

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Collaborator: Shanghai Normal University
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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);