Efficacy of Electroencephalography (EEG) Neurofeedback (NF) of Motor Sensory Cortex as an Add-on Treatment for Drug-naïve Anxiety Disorder: A Randomized, Double-blind, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change of scores in Hamilton Anxiety Rating Scale (HAMD) from baseline to week 2.
研究概览
简要总结
The aim of this study is to assess the efficacy of electroencephalography (EEG) neurofeedback (NF) as an Add-on Treatment for the Anxiety disorder. Meanwhile, evaluate the effect of EEG-NF on cognitive function of Anxiety patients. Furthermore, the investigators will examine the changes in cortisol, gut microbiome and some biomarkers. The hypothesis of this study is that EEG-NF alleviate the anxiety symptoms and improve the cognitive function of Anxiety disorder patients with regulating attention response.
详细描述
This is a randomized, double-blind, sham-controlled study using electroencephalography (EEG) neurofeedback (NF) for 2-week treatment. Participants were randomly assigned 1:1 to NF group or sham-control group. The NF group performed six NF sessions every other day in about two weeks. The feedback value of the NF group was about SMR band, while in the control group was pseudo-random numbers. Apart from studying the effects of EEG-NF on severity of anxiety and cognitive function, the secondary outcomes are to examine biomarkers related to inflammatory activity. Scale assessments are performed before the initiation of treatment, week 1, week 2. The Digit Span test, Go/No-Go task Collection of blood, excrement and saliva takes place at two time points, at the baseline, week 2.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a current episode of Anxiety diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •age between 18 and 50 years
- •a total score of HAMD ≥14 GAD-7≥ 5
- •Participants are compliant with treatment according to the judgement of the treating clinician.
- •Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised.
排除标准
- •History of alcohol or drug abuse;
- •Severe somatic diseases including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma.
- •Use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial
- •Use of immunosuppressive medication such as oral steroid hormones Women in pregnancy or lactation period
研究组 & 干预措施
Experimental:
NF group participants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks combine a selective serotonin reuptake inhibitor (SSRI) or a serotonin or norepinephrine reuptake inhibitors (SNRI) or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics
干预措施: SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics (Drug)
Experimental:
NF group participants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks combine a selective serotonin reuptake inhibitor (SSRI) or a serotonin or norepinephrine reuptake inhibitors (SNRI) or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics
干预措施: Neurofeedback system (Device)
Healthy Experimental:
Participants receive 24 min NF sessions over the Motor sensory Cortex, 2-3 days per week, for 2 weeks
干预措施: Neurofeedback system (Device)
Healthy Sham Comparator
Sham group participants receive 24 min NF sessions with pseudo-random numbers, 2-3 days per week, for 2 weeks
干预措施: Neurofeedback system (Device)
Sham Comparator
Sham Comparator: Sham group participants receive 24 min NF sessions with pseudo-random numbers, 2-3 days per week, for 2 weeks combine a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitors (SNRI), benzodiazepines, tricyclic antidepressants, other antidepressants, antipsychotics, other sedative-hypnotics
干预措施: SSRI or SNRI or benzodiazepines or tricyclic antidepressants or other antidepressants or antipsychotics or other sedative-hypnotics (Drug)
Sham Comparator
Sham Comparator: Sham group participants receive 24 min NF sessions with pseudo-random numbers, 2-3 days per week, for 2 weeks combine a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitors (SNRI), benzodiazepines, tricyclic antidepressants, other antidepressants, antipsychotics, other sedative-hypnotics
干预措施: Neurofeedback system (Device)
结局指标
主要结局
The change of scores in Hamilton Anxiety Rating Scale (HAMD) from baseline to week 2.
时间窗: baseline, Week 1, week 2
The main objective is to explore whether NF add on medicine will improve the anxiety symptoms after 2 weeks of treatment, and investigators assess the scale at baseline and week 1, 2. Hamilton Anxiety Rating Scale (HAMD) items was used to evaluate the severity of symptoms of anxiety. A total score of more than 29 may indicate severe anxiety symptoms; A score above 14 may be mild to moderate anxiety; If the score is less than 7, the patient has no symptoms of anxiety. The higher the total score of the scale, the more severe the anxiety symptoms.
The change of scores in GAD-7 from baseline to week 2.
时间窗: baseline, Week 1, week 2
The main objective is to explore whether NF add on medicine will improve the anxiety symptoms after 2 weeks of treatment, and investigators assess the scale at baseline and week 1, 2. GAD-7 items were used to evaluate the severity of symptoms of anxiety. A total score of more than 15 may indicate severe anxiety symptoms; A score above 5 may be mild to moderate anxiety; If the score is less than 4, the patient has no symptoms of anxiety. The higher the total score of the scale, the more severe the anxiety symptoms.
次要结局
- Adverse events from baseline to week 2(week 1, week 2)
- The change of reaction time in Go/No-Go task from baseline to week 2.(baseline, week 2)
- The change of scores in Self-Rating Anxiety Scale (SAS) from baseline to week 2.(baseline, week 2)
- The changes of levels of biomarkers in peripheral blood from baseline to week 2(baseline, week 2)
- The change of scores in Mindful Attention Awareness Scale, MAAS) from baseline to week 2.(baseline, Week 1, week 2)
- The change of scores in the State-Trait Anxiety Inventory (STAI) from baseline to week 2.(baseline, Week 1, week 2)
- The change of scores in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 2.(baseline, Week 1, week2)
- The change of scores in Insomnia Severity Index (ISI) from baseline to week 2.(baseline, Week 1, week 2)
- The accuracy in the Digit Span test (DSP) from baseline to week 2.(baseline, week 2)