Optimization of ITBS for Depression

Официальное название

Defining Parameters to Optimize Neurostimulation for the Treatment of Pediatric Depression

Обзор

Repetitive TMS (rTMS) is a well-established method for modulating brain activity. Through successive stimulations in the form of magnetic fields, it is possible to modify the sensitivity of neurons in the brain, also known as cortical excitability. Cortical excitability is important for the induction of brain plasticity, the ability of the brain to reorganize itself and form new connections in response to stimuli. A particular class of rTMS, intermittent theta burst TMS (iTBS), is commonly used to modulate cortical excitability and induce plasticity for therapeutic purposes, notably for treatment-resistant depression. Different iTBS stimulation parameters can be used to induce plasticity. This study will focus on two parameters, namely, the form and duration of the electromagnetic stimulation. The shape of the electromagnetic pulse refers to how the electromagnetic wave is configured over time, while the duration is simply the period during which this electromagnetic pulse remains active. These parameters are expected to influence the effectiveness of iTBS in modulating cortical activity but remain little studied. The main aim of this study will be to compare the effectiveness of different stimulation parameters in the induction of plasticity, which will then make it possible to improve the rTMS protocols used for treatment-resistant depression.

Вмешательства

• Устройство Monophasic iTBS
  iTBS protocol with monophasic-shaped pulses. iTBS parameters: * Intensity: 80% of resting motor threshold (rMT) * Frequency: 50 Hz * Duration of pulse train: 2 seconds * Interval between pulse trains: 8 seconds
• Устройство Biphasic iTBS
  iTBS protocol with biphasic-shaped pulses. iTBS parameters: * Intensity: 80% of rMT * Frequency: 50 Hz * Duration of pulse train: 2 seconds * Interval between pulse trains: 8 seconds
• Устройство Monophasic-Long iTBS
  iTBS protocol with long monophasic-shaped pulses. iTBS parameters: * Intensity: 80% of rMT * Frequency: 50 Hz * Duration of pulse train: 2 seconds * Interval between pulse trains: 8 seconds

Первичные конечные точки

• TMS derived measure of cortical plasticity [Срок оценки: Pre-iTBS, Every 5 minutes post iTBS intervention up to 60 minutes post intervention.]

Критерии участия

Критерии включения

• Be between 18 and 35 years old
• Be of right manual dominance
• In good health

Критерии исключения

• Have an implant or pacemaker,
• Having tinnitus,
• Have a history of fainting,
• Have already had an epileptic seizure or have a family history of epilepsy,
• Have a known neurological disease,
• Be under psychotropic medication,
• Have suffered from substance abuse or dependence in the last 6 months,
• Have a neurostimulator,
• Have a splinter or metallic implant in the head or the rest of the body,
• Have a cochlear implant,
• Have an automated injection system implanted (insulin pump),
• Have a transdermal patch,
• Have tattoos in the area to be studied,
• Be pregnant or breastfeeding,

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Канада · 1 центр

• Centre de recherche du Centre hospitalier universitaire de Sherbrook — Sherbrooke

Идентификаторы

NCT: NCT06464445 · 2024-5470

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗