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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active transcranial current stimulation | Active Comparator | 14 daily 20-min, 1.1-mA sessions of active or sham transcranial current stimulation, at the beginning and end of treatment, there is a 30 second period of current fading in and out |
|
| sham transcranial current stimulation | Sham Comparator | only wore the device and had no stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial current stimulation | Device | consecutive daily 20-min, 1.1-mA sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 2 weeks and 3 months |
| Change in regional homogeneity | Regional homogeneity was used to assess the synchronization of local spontaneous brain activity | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks and 3 months |
| the score of 14-item Hamilton anxiety rating scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zan Wang, MD, PhD | Contact | +86 88782678 | wangzan@jlu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of Jilin University | Completed | Ch’ang-ch’un | Jilin | 130021 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42310658 | Derived | Zhang Y, Sun Q, Zhang X, Li W, Wang Y, Cai L, Wang Z. Transcranial direct current stimulation improves reduced global BOLD-CSF coupling in patients with insomnia disorder and comorbid anxiety: a resting-state functional MRI study. BMC Psychiatry. 2026 Jun 17. doi: 10.1186/s12888-026-08304-6. Online ahead of print. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham stimulation | Device | only wore the device and had no stimulation |
|
| 2 weeks and 3 months |
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 |
| 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 | 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 | 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 | 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 | 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 | 2 weeks and 3 months |
| Change in total sleep time (TST) measured by polysomnography | 2 weeks and 3 months |
| Change in sleep onset latency (SOL) measured by polysomnography | 2 weeks and 3 months |
| Change in wake after sleep onset (WASO) measured by polysomnography | 2 weeks and 3 months |
| the First Hospital of Jilin University |
| Recruiting |
| Ch’ang-ch’un |
| Jilin |
| 130021 |
| China |
|
| D001523 |
| Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |