The Effects of Transcranial Current Stimulation on Insomnia

Zan Wang100 enrolled

Overview

Effect of transcranial current stimulation on insomnia disorder

Insomnia disorder represents a prevalent clinical challenge, transcranial current stimulation has emerged as a promising noninvasive therapeutic approach; however, its specific effects on neurophysiological mechanisms underlying sleep-related brain structure and functional change, and neurobiological change remain unclear.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Insomnia, Psychophysiological

Interventions

transcranial current stimulationDEVICE

consecutive daily 20-min, 1.1-mA sessions

Sham stimulationDEVICE

only wore the device and had no stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of insomnia disorder * Cooperate to complete the questionnaire surveys Exclusion Criteria: * 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 * Diagnosis of other sleep disorders, including obstructive sleep apnea, rapid eye movement sleep behavior disorder, or restless legs syndrome * Sleep disorders secondary to organic diseases, such as epilepsy, diabetes, or renal failure * Shift work or irregular work schedules that disrupt normal circadian rhythms * Use of medications affecting central nervous system function within the past one month * Recent sleep-related confounding behaviors within the past two weeks, including staying up late, alcohol consumption, or smoking * Presence of organic brain lesions on head MRI and contraindications to MRI examination

Locations (2)

the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, China

COMPLETED

the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, China

RECRUITING

Outcomes

Primary Outcomes

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 months

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 months

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 months

Change in regional homogeneity

Regional homogeneity was used to assess the synchronization of local spontaneous brain activity

Time frame: 2 weeks and 3 months

Change in phase difference of dynamic cerebral autoregulation

Dynamic cerebral autoregulation was assessed using the phase difference between cerebral blood flow velocity and arterial blood pressure fluctuations. Larger phase differences indicate better autoregulatory function.

Time frame: 2 weeks and 3 months

Change in gain of dynamic cerebral autoregulation

Gain represents the magnitude of cerebral blood flow velocity changes in response to blood pressure fluctuations, with lower gain values indicating more effective autoregulation.

Time frame: 2 weeks and 3 months

Secondary Outcomes

Central Contacts

Zan Wang, MD, PhD

CONTACT

+86 88782678 wangzan@jlu.edu.cn

Data from ClinicalTrials.gov

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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 months

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 months

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 months

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 months

Change in plasma cortisol level

Plasma cortisol concentration was assessed as an indicator of hypothalamic-pituitary-adrenal (HPA) axis function. Higher levels reflect increased physiological stress response. Unit of Measure: μg/dL

Time frame: 2 weeks and 3 months

Change in serum interleukin-6 level

Serum interleukin-6 concentration was measured as a marker of systemic inflammation. Higher levels indicate greater inflammatory activity. Unit of Measure: pg/mL

Time frame: 2 weeks and 3 months

Change in serum brain-derived neurotrophic factor level

Serum brain-derived neurotrophic factor concentration was measured as a biomarker associated with neuroplasticity and neuronal function. Higher levels indicate enhanced neurotrophic activity. Unit of Measure: pg/mL

Time frame: 2 weeks and 3 months

Change in total sleep time (TST) measured by polysomnography

Time frame: 2 weeks and 3 months

Change in sleep onset latency (SOL) measured by polysomnography

Time frame: 2 weeks and 3 months

Change in wake after sleep onset (WASO) measured by polysomnography

Time frame: 2 weeks and 3 months