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

Seoul National University

Status: Completed

Conditions: Primary Insomnia

Treatments: Device: transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02832804

1509-061-703

Details and patient eligibility

About

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

Full 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

Enrollment: 8 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 3 patient groups

anodal stimulation

Experimental group

Description:

10 person The patients treated by anodal stimulation (2mA) for 20 minutes

Treatment:

Device: transcranial Direct Current Stimulation

cathodal stimulation

Active Comparator group

Description:

10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes

Treatment:

Device: transcranial Direct Current Stimulation

sham stimulation

Sham Comparator group

Description:

10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds

Treatment:

Device: transcranial Direct Current Stimulation