Clinical trial NCT05361993: Efficacy of Biofeedback in the Treatment of Tic Disorder
Official title: Efficacy of Biofeedback in the Treatment of Tic Disorder：A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Tic Disorders
Keywords: biofeedback
drug therapy
Clinical Efficacy
Cognitive flexibility
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Normal University
First posted: 2022-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 a randomized controlled study.

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);

Primary outcomes:
measure: Yale global tic severity scale
timeFrame: baseline assessment (T0)
measure: Yale global tic severity scale
timeFrame: assessment after 4 weeks of treatment (T1)
measure: Yale global tic severity scale
timeFrame: assessment after 8 weeks of treatment (T2)
measure: Yale global tic severity scale
timeFrame: 3-month follow-up after completion of treatment (T3).
measure: Wisconsin Card Sorting Test
timeFrame: baseline assessment (T0)
measure: Wisconsin Card Sorting Test
timeFrame: assessment after 4 weeks of treatment (T1)
measure: Wisconsin Card Sorting Test
timeFrame: assessment after 8 weeks of treatment (T2)
measure: Wisconsin Card Sorting Test
timeFrame: 3-month follow-up after completion of treatment (T3)
Secondary outcomes:
measure: Color-word Stroop task
timeFrame: It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
measure: The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
timeFrame: It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
measure: The parent version of Swanson, Nolan, and Pelham-IV(SNAP-IV)
timeFrame: It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
measure: Children' s Depression Inventory(CDI)
timeFrame: It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
measure: The Screen for Child Anxiety Related Emotional Disorders(SCARED)
timeFrame: It's a repeated measurement variable，aseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
measure: Conners' Parent Rating Scale-Revised（CPRS-R）
timeFrame: It's a repeated measurement variable，aseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
measure: The Clinical Global Impression-severity scale
timeFrame: It's a repeated measurement variable，baseline assessment (T0), assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
measure: Clinical Global Impressions-Improvement scale
timeFrame: It's a repeated measurement variable，assessment after 4 weeks of treatment (T1), assessment after 8 weeks of treatment (T2), and 3-month follow-up after completion of treatment (T3)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fundan University
state: Shanghai
Study officials:
References: