The Effects of Transcranial Current Stimulation on Insomnia
ConditionInsomnia, Psychophysiological
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZan Wang
About this trial
Effect of transcranial current stimulation on insomnia disorder
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinical diagnosis of insomnia disorder
Cooperate to complete the questionnaire surveys
Disqualifiers
Presence of mental disorders
Current use of central nervous system stimulants
Use of analgesics,sedatives or hypnotic medications, theophylline preparations, steroid medications
Alcohol abuse or regular alcohol consumption
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial current stimulation
Deviceconsecutive daily 20-min, 1.1-mA sessions
Sham stimulation
Deviceonly wore the device and had no stimulation
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: active transcranial current stimulationActive comparator 1 intervention
Group B: sham transcranial current stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in global blood-oxygen-level-dependent (gBOLD) signal amplitude
The amplitude of the global blood-oxygen-level-dependent (gBOLD) signal was derived from resting-state functional MRI and reflects the overall magnitude of spontaneous brain activity. Unit of Measure: Z-score
Time frame
2 weeks and 3 months2
Change in resting-state functional connectivity strength
Resting-state functional connectivity strength was calculated as the correlation coefficient between predefined brain regions based on functional magnetic resonance imaging data.
Time frame
2 weeks and 3 months3
Change in amplitude of low-frequency fluctuations
Amplitude of low-frequency fluctuations was calculated from resting-state fMRI to quantify spontaneous neural activity.
Time frame
2 weeks and 3 months4
Change in regional homogeneity
Regional homogeneity was used to assess the synchronization of local spontaneous brain activity
Time frame
2 weeks and 3 monthsSecondary outcomes
1
the score of Insomnia Severity Index scale
The total score ranges from 0 to 28, and a higher score indicates higher levels of insomnia severity. A score of 8 or greater is the cut point for clinically possible insomnia
Time frame
2 weeks and 3 months2
the score of 14-item Hamilton anxiety rating scale
The total score ranges from 0 to 56, and a higher score indicates higher levels of anxiety symptoms. A score of 7 or greater is the cut point for clinically possible anxiety
Time frame
2 weeks and 3 months3
the score of 17-item Hamilton depression rating scale
tThe total score ranges from 0 to 52, and a higher score indicates higher levels of depression symptoms. A score of 7 or greater is the cut point for clinically possible depression symptom
Time frame
2 weeks and 3 months4
Change in plasma corticotropin-releasing factor (CRF) level
Plasma corticotropin-releasing factor (CRF) concentration was measured as a biomarker of hypothalamic-pituitary-adrenal (HPA) axis activity. Higher levels indicate increased neuroendocrine stress response. Unit of Measure: pg/mL
Time frame
2 weeks and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zan Wang
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
Source ClinicalTrials.gov