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NCT05361993 | Suspended | Tic Disorders

Efficacy of Biofeedback in the Treatment of Tic Disorder
Sponsor:

Children's Hospital of Fudan University

Information provided by (Responsible Party):

ding Q i Ang

Brief Summary:

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

Condition or disease

Tic Disorders

Intervention/treatment

Drug Aripiprazole

biofeedback

Phase

Phase 4

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 a randomized controlled study.}}

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : Double
Primary Purpose : Treatment
Official Title : Efficacy of Biofeedback in the Treatment of Tic Disorder：A Randomized Controlled Trial
Actual Study Start Date : June 1, 2024
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2027
Arm Intervention/treatment

Experimental: Biofeedback therapy

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.

Device: biofeedback

Active Comparator: Drug therapy

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

Drug: Drug Aripiprazole
Ages Eligible for Study: 8 Years to 16 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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);
Efficacy of Biofeedback in the Treatment of Tic Disorder

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Efficacy of Biofeedback in the Treatment of Tic Disorder

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Locations

Not yet recruiting

China, Shanghai

Children's hospital of Fudan University

Shanghai, Shanghai, China, 201102