Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

Официальное название

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial

Обзор

The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. We hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.

Подробное описание

This is a randomized, double-blind, sham-controlled study to detect the effect of dTMS for treatment of bipolar depression. 100 participants were randomly assigned 1:1 to dTMS group or sham-control group. For both active and sham group, daily dTMS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Based on the original and stable medication, the active stimulation consisted of 55 18 Hz, 2 s trains at 120% motor threshold (MT) intensity, with a between-train interval of 20 s (1980 pulses per day or 39 600 pulses per treatment). The sham stimulation was performed using the same procedures, with the sham coil.

Scale assessments are performed at baseline, week 2, week 4 and week 8. Collection of blood took place at baseline, week 4 and week 8.

Вмешательства

• Устройство deep Transcranial Magnetic Stimulation (dTMS) -active
  with the H1-coil device included 20-min sessions of 18 Hz (2-s trains separated by 20-s inter-train intervals, 55 trains totaling 1980 pulses/session).
• Устройство deep Transcranial Magnetic Stimulation (dTMS) -sham
  The sham stimulation was performed using the same procedures, with the sham coil.

Первичные конечные точки

• The change over time in the score of Hamilton Depression Rating Scale (HDRS-17). [Срок оценки: baseline, week 2, week 4, week 8]

Вторичные конечные точки (5)

• Response and remission rates at weeks 2, week 4 and week 8 with HDRS-17. [Срок оценки: weeks 2, week 4 and week 8]
• The change of scores in MATRICS Consensus Cognitive Battery(MCCB) [Срок оценки: baseline, week 4, week 8]
• The change over time in the score of Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: baseline, week 2, week 4, week 8]
• The changes of levels of Brain Derived Neurotrophic Factor (BDNF) in peripheral blood [Срок оценки: baseline, week 4, week 8]
• The change of scores of adverse events scale from baseline to week 4 [Срок оценки: baseline, week 4]

Критерии участия

Критерии включения

Confirmed diagnosis of bipolar depression;

• age between 18 and 65 years;
• a 17-item Hamilton Depression Rating Scale (HDRS-17) score >= 17,
• a stable pharmacological regimen maintained for at least 4 weeks prior to the beginning of the treatment phase ;
• for participants who had previously received antidepressant therapy, a minimum 4-week washout period followed by re-evaluation.

Критерии исключения

• a lifetime history of other psychiatric disorders, neurological diseases, or severe brain injury;
• receipt of electroconvulsive therapy, rTMS, transcranial direct current stimulation, transcranial alternating current stimulation, or other neurostimulation treatments within the previous 3 months;
• contraindications to magnetic stimulation, including epilepsy, cardiovascular disorders, or metallic implants in the head;
• the presence of hypomanic/manic symptoms at baseline or a score greater than 12 on the Young Mania Rating Scale (YMRS);
• pregnancy or lactation.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Anding Hospital — Тяньцзинь

Публикации

• Chu L, Jia X, Gao P, Sun X, Zhang J, Ding Y, Chen S, Bi F, Zhang C, Li D, Zhang Y. Effects of Deep Transcranial Magnetic Stimulation on Cognitive Function in Bipolar Depression: A Randomized Controlled Trial Using the MATRICS Consensus Cognitive Battery. Alpha Psychiatry. 2026 Feb 28;27(1):47409. doi: 10.31083/AP47409. eCollection 2026 Feb. PMID 41788133

Идентификаторы

NCT: NCT06524505 · dTMS-TJAH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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