Model-Driven Individualized Transcranial Direct Current Stimulation for the Treatment of Insomnia Disorders

Обзор

This study is designed to evaluate the efficacy and to explore the best individualized stimulus paradigm of transcranial Electrical Stimulation for insomnia patients.

Подробное описание

This study employs a randomized double-blind placebo-controlled design, with blinding applied to both the assessors and patients, while the therapists remain unblinded. A total of 40 patients with insomnia disorders meeting the inclusion criteria were recruited from the Shanghai Mental Health Center and randomly assigned to either the tDCS active stimulation group or the tDCS sham stimulation group, with 20 patients in each group. All patients underwent clinical assessments, magnetic resonance imaging (MRI) scans, and high-density electroencephalogram (EEG) parameter collections at baseline. Based on the MRI structural images and high-density EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation sites, stimulation intensity, and electrode placement methods). Detailed modeling methods and selection of stimulation parameters can be found in the intervention methods section. Stimulation was carried out for a total of 2 weeks, with one session per day on weekdays, totaling 10 sessions, each lasting thirty minutes.

Вмешательства

• Устройство Active transcranial direct current stimulation
  The intervention uses transcranial direct current stimulation (tDCS). The targeted brain regions are identified by conducting simultaneous fMRI-EEG data collection and sleep staging, comparing fMRI data between wakefulness and sleep states. Brain regions that show differences are calculated as potential targets for electrical stimulation. If no differentiated regions are found in a participant, specific areas are chosen based on individualized modeling results from previous experiments, targetin
• Устройство Sham transcranial direct current stimulation
  In the sham stimulation group, the placement of the tDCS electrodes is identical to that of the active stimulation group. After the stimulation begins, the current gradually increases over 15 seconds. However, upon reaching the therapeutic current level, it immediately begins to decrease, lowering to 0 mA within 15 seconds and remaining at 0 mA throughout the rest of the session. During the last 15 seconds of the stimulation, there is another gradual decrease in current to 0 mA. This approach cr

Первичные конечные точки

• Insomnia Severity Index change [Срок оценки: The study endpoint is set at 2 weeks after the end of treatment]

Вторичные конечные точки (5)

• Insomnia Severity Index score change [Срок оценки: after tDCS intervention and 4 weeks post-intervention]
• response/remission rate [Срок оценки: After tDCS intervention, 2 weeks post-intervention, and 4 weeks post-intervention]
• Sleep onset latency, sleep efficiency, and nighttime sleep duration (as defined by the sleep diary). [Срок оценки: After tDCS intervention and 2 weeks post-tDCS intervention]
• Hamilton Depression Rating Scale-17 change [Срок оценки: After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention]
• Hamilton Anxiety Rating Scale Change [Срок оценки: After tDCS intervention, 2 weeks post-tDCS intervention, and 4 weeks post-intervention]

Критерии участия

Критерии включения

• Age between 18 and 65 years;
• Meets the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
• Has not taken psychiatric medications in the 8 weeks prior to enrollment or has been on stable psychiatric medication for 8 weeks (excluding benzodiazepines);
• Insomnia severity as indicated by an ISI score > 10;
• Minimum education level of junior high school or above.

Критерии исключения

• Past or current diagnosis of disorders other than insomnia disorder, anxiety disorder, or depressive disorder according to DSM-5;
• Currently using benzodiazepines as sleep aids;
• Moderate to severe anxiety or depression (HAMD-17 score > 16 or HAMA score > 24);
• Patients with obstructive sleep apnea syndrome;
• Previous treatment with ECT, rTMS, tES, or cognitive behavioral therapy for insomnia disorder;
• Severe physical illnesses or any condition that may induce seizures or intracranial hypertension, including cardiovascular or respiratory diseases;
• History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or history of brain injury or brain surgery;
• Presence of implantable medical devices such as intracranial stents, cardiac pacemakers, coronary stents, or cochlear implants;
• Severe negative thoughts or high suicide risk;
• Pregnant or planning to conceive in the near future.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Mental Health Center — Шанхай

Публикации

• Wang Y, Jia W, Zhang Z, Bai T, Xu Q, Jiang J, Wang Z. Model-driven individualized transcranial direct current stimulation for the treatment of insomnia disorder: protocol for a randomized, sham-controlled, double-blind study. BMC Psychiatry. 2025 Sep 26;25(1):869. doi: 10.1186/s12888-025-07347-5. PMID 41013363

Идентификаторы

NCT: NCT06671457 · SMHC-ISM-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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