Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464172
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-10
Brief Title:
Association Between Serum and Neuroimaging Measurements of the GABAergic System
Sponsor:
Francois Corbin
Organization:
Université de Sherbrooke
Study Overview
Official Title:
The GABAergic System Study of the Association Between Serum Measurements and Those Obtained Through Neuroimaging in Healthy Human Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-5398 | OTHER | None | None |