Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients

Study Overview
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Brief Summary
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To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .

Detailed Description
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visit 1 to fill in a questionnaire (Clinical Global Impression, CGI; Leeds Sleep Evaluation Questionnaire, LSEQ; Stanford Sleepiness Scale, SSS; Hospital Anxiety and Depression Scale, HADS; 36-Item Short Form Survey, SF-36) EEG visit 2-6 tDCS stimulation (monday   friday) anodal / cathodal / sham to fill in a questionnaire (CGI, LSEQ, SSS, HADS) analysis the results of sleep log and actigraphy visit 7 : 1 week after treatment to fill in a questionnaire (CGI, LSEQ, SSS, HADS) analysis the results of sleep log and actigraphy EEG visit 8 : 1 month after treatment to fill in a questionnaire (CGI, LSEQ, SSS, HADS, SF-36) analysis the results of sleep log

Official Title
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Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients

Conditions
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Primary Insomnia

Intervention / Treatment
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* Device: transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult (older than 19 years) primary insomnia right handed agree with participation of this study Exclusion Criteria: diagnosed with epilepsy or history of seizure change of antipsychotic drug within 1 month under suspicion of sleep apnea or periodic limb movement disorder mental retardation (IQ < 70) pregnant woman

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anodal stimulation<br>10 person The patients treated by anodal stimulation (2mA) for 20 minutes | Device: transcranial Direct Current Stimulation<br>* Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds<br>* Other names: HDCstim (direct current stimulator);|
| Active Comparator: cathodal stimulation<br>10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes | Device: transcranial Direct Current Stimulation<br>* Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds<br>* Other names: HDCstim (direct current stimulator);|
| Sham Comparator: sham stimulation<br>10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds | Device: transcranial Direct Current Stimulation<br>* Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds<br>* Other names: HDCstim (direct current stimulator);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep log and actiwatch | Changes of sleep quality | Change from baseline at 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire |  | Change from baseline at 1 month | 
| EEG spectrum analysis |  | Change from baseline at 1 month | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Change from baseline at 1 month |