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

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

Study Overview

• Status: Completed
• Conditions: Primary Insomnia
• Intervention / Treatment: Device: transcranial Direct Current Stimulation

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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anodal stimulation; 10 person The patients treated by anodal stimulation (2mA) for 20 minutes	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; Other Names: HDCstim (direct current stimulator)
Active Comparator: cathodal stimulation; 10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes	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; Other Names: HDCstim (direct current stimulator)
Sham Comparator: sham stimulation; 10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds	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; Other Names: HDCstim (direct current stimulator)

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Ki-Young Jung, professor, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): September 30, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 1509-061-703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided