Clinical Efficacy and Mechanism of rTMS Based on dlPFC in the Intervention of Generalized Anxiety Disorder With Insomnia

Официальное название

Clinical Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation Based on dlPFC in the Intervention of Generalized Anxiety Disorder With Insomnia: An Open-label Study

Обзор

To investigate the intervention effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on insomnia symptoms of generalized anxiety disorder patients.

Подробное описание

Stimulation was performed using a figure 8-shaped focal coil attached to a MagPro 100 magnetic stimulator (MagVenture, Copenhagen, Denmark). All patients received 1 Hz (10 s trains, 1 s inter-train interval, 1,360 pulses per session) rTMS treatment once daily on weekdays for 2 consecutive weeks. rTMS was delivered over the right DLPFC (F4 electrode site according to the International 10-20 EEG system) at 100% of the resting motor threshold (RMT) . To determine the RMT, stimulus intensity was gradually increased until 5 out of 10 trials elicited motor evoked potentials with peak-to-peak amplitudes over 50 μV in the contralateral abductor pollicis brevis muscle. Adverse events attributed to rTMS were documented and reported. All participants received a pre-treatment assessment with the PSQI, HAMA, and HAMD. We used the PSQI to measure sleep quality, as well as HAMA and HAMD to assess participant's anxious and depressive states. Likewise, the PSQI was measured post-treatment (upon completion of the final treatment session) and at 1-month follow-up.

Вмешательства

• Устройство Repetitive Transcranial Magnetic Stimulation
  Repetitive transcranial magnetic stimulation (rTMS) can noninvasively modulate cortical activity by delivering a sequence of magnetic pulses.
• Устройство Sham Repetitive Transcranial Magnetic Stimulation
  Sham tDCS was delivered using the same protocol and current intensity, but it is carried out as the coil is turned away from the skull at 90°.

Первичные конечные точки

• subjective sleep quality assessed by the PSQI [Срок оценки: before and after 10-day intervention and at 1-month follow-up]
• subjective sleep quality assessed by the ISI [Срок оценки: before and after 10-day intervention and at 1-month follow-up]
• emotional symptoms assessed by the HAMA [Срок оценки: before and after 10-day intervention and at 1-month follow-up]

Вторичные конечные точки (1)

• emotional symptoms assessed by the HAMD [Срок оценки: before and after 10-day intervention and at 1-month follow-up]

Критерии участия

Критерии включения

• age between 15 and 65 years;
• clinically diagnosed with anxiety according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V);
• no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.

Критерии исключения

• current or history of serious brain and body diseases;
• current or history of schizophrenia, behavioral problems, post-traumatic stress disorder, mania, obsessive-compulsive disorder, and social phobia;
• substance abuse or other comorbid psychological diseases.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT06931236 · AHMU-TMS-GADIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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