Association Between Serum and Neuroimaging Measurements of the GABAergic System

Официальное название

The GABAergic System: Study of the Association Between Serum Measurements and Those Obtained Through Neuroimaging in Healthy Human Adults

Обзор

The goal of this study is to better understand the relationship between peripheral and central nervous system measurements of the gamma-aminobutyric acid (GABA) system in otherwise healthy individuals. the main questions it aims to answer are: 1. Does GABA cross the blood-brain barrier? 2. Can peripheral measurements of the GABAergic system be used to study GABA in the brain? Participants will receive oral GABA and Placebo and undergo blood draws, MRI scans and transcranial magnetic stimulation sessions.

Подробное описание

Although gamma-aminobutyric acid (GABA) is the main inhibitory neurotransmitter in the central nervous system in humans, and various pharmacological compounds and natural products aim to modulate it, it is still unknown whether GABA can cross the blood-brain barrier. The present project aims to clarify this issue by comparing measurements obtained in the central nervous system (the brain) with peripheral measurements (serum) following oral administration of the amino acid GABA. This will help determine if peripheral concentrations of GABA in the blood reflect levels in the brain. This would facility studying the GABAergic system in vulnerable clinical populations (such as children or patients with intellectual disabilities) to participate in without resorting to expensive neuroimaging exams and the inclusion of individuals who cannot undergo neuroimaging exams (e.g., claustrophobia, presence of metal in the body). To achieve this, GABA measurements (serum and neuroimaging) will be obtained before and after the oral intake of 1800mg of GABA or a placebo in 30 healthy adults participating in a cross-over, single-blind study with repeated measures.

Вмешательства

• Другое Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada)
  1800 mg (3 capsules of 600mg) of GABA taken at the research center under the supervision of the research team.
• Другое Acute Placebo
  A capsule filled with powdered sugar taken under the supervision of the research team.

Первичные конечные точки

• Impact of Acute GABA consumption on peripheral serum GABA concentrations [Срок оценки: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo]
• Impact of Acute GABA consumption on short intracortical inhibition [Срок оценки: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo]

Вторичные конечные точки (4)

• Impact of Acute GABA consumption on short intracortical facilitation [Срок оценки: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo]
• Impact of Acute GABA consumption on GABA concentrations in the brain [Срок оценки: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo]
• Impact of Acute GABA consumption on subjective alertness [Срок оценки: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo]
• Impact of Acute GABA consumption on objective alertness [Срок оценки: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo]

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,
• Have a diagnosis of diabetes
• 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,
• Being claustrophobic or having other reasons that would prevent the volunteer from tolerating the imaging exam.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06464172 · 2024-5398 · 2024-5398

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗