Efficacy of Biofeedback in the Treatment of Tic Disorder：A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Yale global tic severity scale
研究概览
简要总结
To investigate the efficacy of EEG biofeedback and drug therapy in the treatment of tic disorders
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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);
研究组 & 干预措施
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.
干预措施: biofeedback (Device)
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
干预措施: Drug Aripiprazole (Drug)
结局指标
主要结局
Yale global tic severity scale
时间窗: 3-month follow-up after completion of treatment (T3).
Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.
Wisconsin Card Sorting Test
时间窗: 3-month follow-up after completion of treatment (T3)
The participants were asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changed discreetly from color to form or number of figures without the participants being informed. The participants had to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties were indicated by preservative errors; thus, higher scores on this test represent worse performance.
次要结局
- Color-word Stroop task(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))
- The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)(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))
- The parent version of Swanson, Nolan, and Pelham-IV(SNAP-IV)(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))
- Children' s Depression Inventory(CDI)(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))
- The Screen for Child Anxiety Related Emotional Disorders(SCARED)(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))
- Conners' Parent Rating Scale-Revised（CPRS-R）(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))
- The Clinical Global Impression-severity scale(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))
- Clinical Global Impressions-Improvement scale(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))
研究者
Ding Qiang
Clinical Psychotherapist
Children's Hospital of Fudan University