Investigating the Neural Mechanisms of Repetitive Brain Stimulation With Invasive and Noninvasive Electrophysiology in Humans

Обзор

Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but clinical outcome is suboptimal, partially because investigators are missing biologically-grounded brain markers which show that TMS is modifying activity at the intended target in the brain. The goal of this proposal is to characterize the key markers of the brain's response to repeated doses of TMS with high resolution using invasive brain recordings in humans, and relate these brain markers to noninvasive recordings. These markers will improve the understanding of TMS and can be used to optimize and enhance clinical efficacy for depression and other psychiatric disorders.

Подробное описание

Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder, but remission rates are 20-40%, and ideal stimulation parameters are unknown. rTMS is thought to work by changing the synaptic strength of neurons. The ability of the brain to make these changes is referred to as plasticity. rTMS-induced changes are thought to build with successive treatment sessions, a process referred to as metaplasticity. While both plasticity and metaplasticity are well-established in single cell physiology, relevance to rTMS in humans remains unknown. To improve clinical efficacy, the investigators need to understand 1) the neural response to a single rTMS session (plasticity), 2) the neural response to repeated daily rTMS sessions (metaplasticity), and 3) whether computational models of plasticity based on single-cell physiology apply to human patients receiving rTMS for depression.

Goals of the study are to 1) establish a detailed mechanistic understanding of the brain changes during current rTMS treatment; 2) identify clinically meaningful electrophysiological biomarkers for rTMS treatment; 3) establish a computational model to help predict both brain and clinical changes.

Вмешательства

• Устройство Intracranial electrodes
  Intracranial electrodes will be used for the delivery of invasive brain stimulation.
• Устройство TMS
  TMS will be used for the delivery of noninvasive brain stimulation both before and after implantation electrode surgery.

Первичные конечные точки

• TMS-iEEG change after one TBS session [Срок оценки: 45 minutes]

Вторичные конечные точки (3)

• ES-iEEG change after one TBS session [Срок оценки: 45 minutes]
• ES-iEEG change between two sequential TBS sessions [Срок оценки: 45 minutes]
• TMS-iEEG change between two sequential TBS sessions [Срок оценки: 45 minutes]

Критерии участия

Критерии включения

• Men and women, ages 18 to 65
• Medication-refractory epilepsy requiring phase II monitoring
• Must have intellectual capacity to ensure adequate comprehension of the study and potential risks involved in order to provide informed consent
• No current or history of major neurological disorders other than epilepsy

Критерии исключения

• Those with a contraindication for MRIs (e.g. implanted metal)
• Any unstable medical condition
• Neurological or uncontrolled medical disease
• Active substance abuse
• Currently pregnant or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Stanford University — Stanford

Идентификаторы

NCT: NCT05996900 · 11354-1 · 1R01MH132074

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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