Clinical trial
Efficacy of Biofeedback in the Treatment of Tic Disorder：A Randomized Controlled Trial
Name
TD_BF_RCT20220318
Description
To investigate the efficacy of EEG biofeedback and drug therapy in the treatment of tic disorders
Trial arms
Trial start
2024-06-01
Estimated PCD
2026-12-31
Trial end
2027-12-31
Phase
Early phase I
Treatment
Drug Aripiprazole
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
Arms:
Drug therapy
biofeedback
Biofeedback therapy 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，Thought Technology Ltd.）.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.
Arms:
Biofeedback therapy
Size
40
Primary endpoint
Yale global tic severity scale
baseline assessment (T0)
Yale global tic severity scale
assessment after 4 weeks of treatment (T1)
Yale global tic severity scale
assessment after 8 weeks of treatment (T2)
Yale global tic severity scale
3-month follow-up after completion of treatment (T3).
Wisconsin Card Sorting Test
baseline assessment (T0)
Wisconsin Card Sorting Test
assessment after 4 weeks of treatment (T1)
Wisconsin Card Sorting Test
assessment after 8 weeks of treatment (T2)
Wisconsin Card Sorting Test
3-month follow-up after completion of treatment (T3)
Eligibility 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);
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-03-08
1 organization
Organization
Children's Hospital of Fudan University