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NCT Number: NCT06464172

Association Between Serum and Neuroimaging Measurements of the GABAergic System

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada)

Other

1800 mg (3 capsules of 600mg) of GABA taken at the research center under the supervision of the research team.

Other names: GABA

Acute Placebo

Other

A capsule filled with powdered sugar taken under the supervision of the research team.

Primary outcomes

  1. Impact of Acute GABA consumption on peripheral serum GABA concentrations

    Time frame: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo

    Serum GABA concentration will be measured before and after acute administration of GABA and placebo.

  2. Impact of Acute GABA consumption on short intracortical inhibition

    Time frame: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo

    TMS-derived measure of Intracortical inhibition: The degree of decrease of peak-to-peak motor evoked potential (MEP) amplitude induced by the administration of a conditioning stimulus (set at 70% of resting motor threshold) 2-4 ms before the test stimulus (stimulation intensity required to produce an MEP of 1 millivolt (mV), approximately 120% of resting motor threshold)

Secondary outcomes

  1. Impact of Acute GABA consumption on short intracortical facilitation

    Time frame: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo

    Transcranial magnetic stimulation (TMS) -derived measure of Intracortical facilitation: The degree of increase of peak-to-peak motor evoked potential (MEP) amplitude induced by the administration of a conditioning stimulus (set at 80% of resting motor threshold) 12-24 ms before the test stimulus (stimulation intensity required to produce an MEP of 1 mV, approximately 120% of resting motor threshold).

  2. Impact of Acute GABA consumption on GABA concentrations in the brain

    Time frame: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo

    Estimation of GABA concentrations in the brain from magnetic resonance spectroscopy

  3. Impact of Acute GABA consumption on subjective alertness

    Time frame: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo

    Subjective alertness will be measured using the Biphasic Alcohol Alertness Scale (BAES). This scale which measures alertness and sedation and is comprised of 6 items, for each item participants rate how they feel from 1 (not at all) to 10 (extremely)

  4. Impact of Acute GABA consumption on objective alertness

    Time frame: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo

    Objective alertness will be measured using the psychomotor vigilance task (PVT). This computerised task measures alertness, participants will have to respond to visual cues that are presented at random intervals on the screen.

Study contacts

Contact information is provided by the study sponsor or research team.

François Corbin, MD, Ph.D.

CONTACT

[email protected]

819-346-1110 ext. 15801

Samantha Cote, Ph.D.

CONTACT

[email protected]

819-346-1110 ext. 70184

Sponsors and collaborators

Lead sponsor

Francois Corbin

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.