NCT02832804

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

* 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

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DEVICE	transcranial Direct Current Stimulation	Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-09-30
• Completion: 2017-05-01
• First posted: 2016-07-14
• Last updated: 2021-09-24

Locations

1 site across 1 country: South Korea