Association Between Serum and Neuroimaging Measurements of the GABAergic System

NCT06464172 | Not Yet Recruiting

• 1 other identifier: 2024-5398
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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. 1.Does GABA cross the blood-brain barrier?
2. 2.Can peripheral measurements of the GABAergic system be used to study GABA in the brain?

Conditions

GABAergic System

Keywords

GABAergic system; Neuroimaging; Transcranial Magnetic Stimulation; Magnetic Resonance Spectroscopy

Outcome Measures

Primary Outcomes (2)

• Impact of Acute GABA consumption on peripheral serum GABA concentrations

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

  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

  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)

  Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo

Secondary Outcomes (4)

• Impact of Acute GABA consumption on short intracortical facilitation

  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

  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

  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

  Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo

Study Arms (2)

GABA Start Group

EXPERIMENTAL

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.

Other: Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada); Other: Acute Placebo

Placebo Start Group

EXPERIMENTAL

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.

Other: Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada); Other: Acute Placebo

Interventions

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.

Also known as: GABA

GABA Start Group; Placebo Start Group

Acute Placebo OTHER

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

GABA Start Group; Placebo Start Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Francois Corbin: lead

MeSH Terms

Interventions

gamma-Aminobutyric Acid

Intervention Hierarchy (Ancestors)

Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

François Corbin, MD, Ph.D.

CONTACT

819-346-1110; Francois.Corbin@USherbrooke.ca

Samantha Cote, Ph.D.

CONTACT

819-346-1110; Samantha.cote@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research team will conduct the randomization and participant code allocation process using REDCap and will dispense the medication or placebo based on the randomization. The placebo will be visibly identical to that of the active medication (i.e. white powder in a gel capsule of the same size and colour as the active medication)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full professor, Department of biochemistry

Model Details: Randomized, crossover, single-blind, placebo-controlled design

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 18, 2024
• Study Start: May 5, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02