Association Between Serum and Neuroimaging Measurements of the GABAergic System

NCT ID: NCT06464172

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2026-07-01

Brief Summary

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.

Detailed Description

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.

Conditions

GABAergic System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

GABA Start Group

Participants who are randomly assigned to the GABA start group. These participants receive GABA at the first experimental visit and the placebo at the second experimental visit.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Acute Placebo

Intervention Type: OTHER

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

Placebo Start Group

Participants who are randomly assigned to the Placebo start group. These participants will receive a placebo at the first experimental visit and GABA at the second experimental visit.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Acute Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Acute Placebo

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

Intervention Type: OTHER

Other Intervention Names

GABA

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Francois Corbin

OTHER

Sponsor Role: lead

Responsible Party

Francois Corbin

Full professor, Department of biochemistry

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

François Corbin, MD, Ph.D.

Role: CONTACT

Francois.Corbin@USherbrooke.ca

819-346-1110 ext. 15801

Samantha Cote, Ph.D.

Role: CONTACT

Samantha.cote@usherbrooke.ca

819-346-1110 ext. 70184

Other Identifiers

2024-5398

Identifier Type: OTHER

Identifier Source: secondary_id

2024-5398

Identifier Type: -

Identifier Source: org_study_id