Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- anxiety symptoms
研究概览
简要总结
To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on anxiety symptoms and somatic symptoms in patients with anxiety disorder and its underlying neural mechanism by MRI.
详细描述
Anxiety is characterized by excessive fear, anxiety, or avoidance of a range of external and internal stimuli. Somatic symptoms often co-occur with anxiety and are part of the manifestation of anxiety. The purpose of this study was to explore the relieving effect of high definition transcranial direct current stimulation (HD-tDCS) on the symptoms of anxiety.
60 patients with anxiety disorder diagnosed by DSM-5 were recruited from the fourth people's Hospital of Hefei and the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving HD-tDCS. After meeting the inclusion criteria and obtaining informed consent, each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and HD-tDCS treatment conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of Anhui Medical University. All the participants were randomized (1:1) to receive "active" or "sham" treatment protocol. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Before and after the HD-tDCS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included MoCA, Stroop Test, VFT, DST, AVLT, HAMD, HAMA, PHQ15, BSS(Beck scale for suicide ideation),ISI,SDS, RRS, TEPS, AES, FPQ, PVAQ and AAS. Multimodal fMRI includes 3D-T1, rs-fMRI, DTI and ASL.
Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24 hours after the last treatment. The symptoms of the patients were followed up one month after the end of treatment.They were instructed to focus their answers on the past week. Afterwards, they were unblinded by the study coordinator.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for anxiety, and HAMA>14, PHQ-15>
- •the age ranged from 18 to 60 years old, and the length of education was more than 5 years.
- •the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.
排除标准
- •accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
- •accompanied by other neurological diseases, such as stroke, epilepsy and so on.
- •pregnant and lactating women.
- •accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on.
- •patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker, cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc.
- •those who could not cooperate with those who completed the relevant experiments, such as patients with depressive stupor, claustrophobia and so on.
研究组 & 干预措施
real stimulation
Participants will receive active tDCS once daily for two weeks. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions.
干预措施: High definition transcranial direct current stimulation (Device)
sham stimulation
Participants will receive sham tDCS once daily for two weeks. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
干预措施: sham high definition transcranial direct current stimulation (Device)
结局指标
主要结局
anxiety symptoms
时间窗: baseline and immediately after intervention
the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to dDCS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
resting-state functional connectivity
时间窗: baseline and immediately after intervention
the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI.
次要结局
- ISI(The insomnia severity index)(baseline and immediately after intervention)
- SAS(Self-rating anxiety scale)(baseline and immediately after intervention)
- somatic symptoms(baseline and immediately after intervention)
- 4DSQ-Som(Four-DimensionalSymptomQuestionnaire)(baseline and immediately after intervention)
- HAMD(Hamilton Depression Scale)(baseline and immediately after intervention)
研究者
WANG KAI
Director of medical psychological department, Anhui Medical University
Anhui Medical University