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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02832804

Enrollment

Registered

2016-07-14

Start date

2016-02-29

Completion date

2017-05-31

Last updated

2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia

Brief 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

Interventions

DEVICEtranscranial 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
sleep log and actiwatch	Change from baseline at 1 week	Changes of sleep quality

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026