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治験 NCT07340268（対象：精神生理性不眠症）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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The Effects of Transcranial Current Stimulation on Insomnia 100
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07340268 は 介入研究 臨床試験 で、精神生理性不眠症 に関するものです。現在は 募集中 で、2026年1月18日 から開始しています。100 名の参加者 の募集が計画されています。この試験は Zan Wang によって主導され、2026年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月4日 です。
概要
Effect of transcranial current stimulation on insomnia disorder
詳細説明
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.
公式タイトル
The Effects of Transcranial Current Stimulation on Insomnia
疾患名
精神生理性不眠症その他の研究識別子
- TCS-V01
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
四重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬active transcranial current stimulation 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 | transcranial current stimulation consecutive daily 20-min, 1.1-mA sessions |
シャム対照薬sham transcranial current stimulation only wore the device and had no stimulation | 偽刺激 only wore the device and had no stimulation |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. | 2 weeks and 3 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 | 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 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Clinical diagnosis of insomnia disorder
- Cooperate to complete the questionnaire surveys
- 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
Zan Wang責任者
Zan Wang, 治験依頼者・主任研究者, Sleep Center Director, The First Hospital of Jilin University
試験中央連絡先
連絡先: Zan Wang, MD, PhD, +86 88782678, [email protected]
2 1カ国の場所
Jilin
the First Hospital of Jilin University, Ch’ang-ch’un, Jilin, 130021, China
完了
the First Hospital of Jilin University, Ch’ang-ch’un, Jilin, 130021, China
Zan Wang Prof, PhD, 連絡先, +86-13843025938, [email protected]
募集中