Efficacy of Biofeedback in the Treatment of Tic Disorder

Fudan University

Status and phase: Suspended; Phase 4

Conditions: Tic Disorders

Treatments: Device: biofeedback; Drug: Drug Aripiprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05361993

TD_BF_RCT20220318

Details and patient eligibility

About

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

Full 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 a randomized controlled study.

Enrollment: 40 estimated patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Biofeedback therapy

Experimental group

Description:

three times a week, every other day interval, 30 minutes each time, each subject received 20 biofeedback training (using the Infiniti3000A biofeedback system Patients in the theta group decreased the theta amplitude at Cz. Patients in the theta group received positive feedback when their theta activity was below the feedback threshold.

Treatment:

Device: biofeedback

Drug therapy

Active Comparator group

Description:

Considering the patients with chronic tic disorder (chronic motor or vocal tic disorder or Tourette's disorder), aripiprazole was selected as a single drug with constant dose during the treatment. In case of extrapyramidal side effects, benhexol was given to reduce the extrapyramidal side effects, and the dosage and duration of medication were recorded

Treatment:

Drug: Drug Aripiprazole