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Набор скоро начнётся NCT07271524

Non-invasive Deep Brain Stimulation to Improve Spatial Navigation Abilities in Individuals Following Traumatic Brain Injury

Без фазы С лечением Traumatic Brain Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcranial electric stimulation.
Кому может быть актуально
Состояния в реестре: Traumatic Brain Injury. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Investigation of the Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging (PlasMA)

Обзор

Impairments in spatial memory and spatial navigation are commonly reported amongst patients presenting post-traumatic brain injury (TBI). In this study, the investigators examine the effect of non-invasive deep brain stimulation of the hippocampal-entorhinal complex (HC-EC), a key region supporting navigation abilities, on spatial navigation performance in TBI patients. Using a virtual reality task where participants must first encode and later recall the location of objects in a virtual arena, the investigators contrast performance while active versus control stimulation is applied to the HC-EC. The investigators additionally record brain activity using electroencephalography (EEG) prior to, during, and after task performance to characterize the neural correlates of spatial navigation abilities in TBI patients, and how they are affected by stimulation.

Подробное описание

Patients will perform a virtual reality spatial navigation task comparable to that used previously by Beanato and colleagues (2024; DOI: 10.1126/sciadv.ado4103). Patients will perform 4 blocks of task, each lasting approximately 10 minutes; during the full duration of each block, either active or control transcranial temporal interference stimulation (tTIS) will be applied in an interleaved manner, and EEG recordings will be collected. Resting-state EEG recordings will also be collected prior to and following task performance.

Structural, diffusion-weighted, and resting-state MRI scans will additionally be performed during a prior baseline session.

Вмешательства

  • Другое Transcranial electric stimulation
    Transcranial temporal interference stimulation (tTIS) is an innovative non-invasive brain stimulation approach, in which two or more independent stimulation channels deliver high-frequency currents in the kHz range (oscillating at f1 and f1 + Δf). These high-frequency currents are assumed to be too high to effectively modulate neuronal activity. Still, by applying a small shift in frequency, they result in a modulated electric field with the envelope oscillating at the low-frequency Δf (target f

Первичные конечные точки

  • Speed in the spatial navigation task [Срок оценки: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)]
  • Accuracy in the spatial navigation task [Срок оценки: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)]
Вторичные конечные точки (2)
  • Brain oscillatory activity [Срок оценки: Peri-interventional (up to 1 hour; approximate duration of intervention = 40 minutes, administered in a single session)]
  • Brain structure and connectivity [Срок оценки: Baseline (before the intervention)]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Clinical diagnosis of TBI
  • No history of other severe neurological or psychiatric disorders

Критерии исключения

  • Unable to consent
  • Severe neuropsychiatric (e.g., major depression, severe dementia) or unstable systemic diseases (e.g., severe progressive and unstable cancer, life threatening infectious diseases)
  • Severe sensory or cognitive impairment or musculoskeletal dysfunctions prohibiting to understand instructions or to perform the experimental tasks
  • Inability to follow or non-compliance with the procedures of the study
  • Contraindications for NIBS or MRI:
  • Electronic or ferromagnetic medical implants/device, non-MRI compatible metal implant
  • History of seizures
  • Medication that significantly interacts with NIBS being benzodiazepines, tricyclic antidepressants and antipsychotics
  • Regular use of narcotic drugs
  • Pregnancy
  • Request of not being informed in case of incidental findings
  • Concomitant participation in another trial involving probing of neuronal plasticity

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
Четверное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Швейцария · 2 центра
  • EPFL, Campus Biotech — Geneva
  • EPFL Valais, Clinique Romande de readaptation — Sion

Идентификаторы

NCT: NCT07271524 · 2020-00127-wp73t · 2020-00127

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗