Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04791124
Status:
UNKNOWN
Last Update Posted:
2021-03-10
First Post:
2021-03-05
Brief Title:
Assessment of Neural Oscillations in Adult Subjects With Down Syndrome and Typically Developing Subjects in Resting State and While Conducting Cognitive Tasks
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Assessment of Neural Oscillations in Adult Subjects With Down Syndrome and Typically Developing Subjects in Resting State and While Conducting Cognitive Tasks
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
EEGDS
Brief Summary:
Background
It has been proposed that a hyperactivity of the endocannabinoids system could be involved in the cognitive deficits involved in Down Syndrome DS Hyperactivation of the type-1 cannabinoid CB1 receptor by exogenous cannabinoids such as the active principle of cannabis tetrahydrocannabinol THC induces several modifications of the electroencephalogram EEG
The goal of this study is to compare those CB1-dependent EEG parameters in subjects with DS and age-matched typically developing subjects TD control group These investigations can increase our knowledge of the involvement of the CB1 receptor in DS cognitive deficits and potentially identify biomarkers of target engagement of new therapies of this condition
Hypothesis
It was recently showed in pre-clinical DS models that the endocannabinoid system is hyperactivated in the brain and that human adult subjects with DS showed higher plasma concentrations of the main endocannabinoids 2-arachidonoylglycerol 2-AG and anandamide N-arachidonoylethanolamine 2-AEA as compared with those found in typically developing subjects Alterations of neural oscillations induced by the consumption of THC preparations are well established and it is hypothesized that they would be similar to those found in subjects with DS
Objectives
To assess different neural markers using electroencephalography EEG in typically developing subjects and in subjects with DS in resting state and while conducting selected cognitive tasks
Methods
Non-interventional cross-sectional monocenter study in male and female adult subjects with DS and typically developing subjects total n48
It has been proposed that a hyperactivity of the endocannabinoids system could be involved in the cognitive deficits involved in Down Syndrome DS Hyperactivation of the type-1 cannabinoid CB1 receptor by exogenous cannabinoids such as the active principle of cannabis tetrahydrocannabinol THC induces several modifications of the electroencephalogram EEG
The goal of this study is to compare those CB1-dependent EEG parameters in subjects with DS and age-matched typically developing subjects TD control group These investigations can increase our knowledge of the involvement of the CB1 receptor in DS cognitive deficits and potentially identify biomarkers of target engagement of new therapies of this condition
Hypothesis
It was recently showed in pre-clinical DS models that the endocannabinoid system is hyperactivated in the brain and that human adult subjects with DS showed higher plasma concentrations of the main endocannabinoids 2-arachidonoylglycerol 2-AG and anandamide N-arachidonoylethanolamine 2-AEA as compared with those found in typically developing subjects Alterations of neural oscillations induced by the consumption of THC preparations are well established and it is hypothesized that they would be similar to those found in subjects with DS
Objectives
To assess different neural markers using electroencephalography EEG in typically developing subjects and in subjects with DS in resting state and while conducting selected cognitive tasks
Methods
Non-interventional cross-sectional monocenter study in male and female adult subjects with DS and typically developing subjects total n48
Detailed Description:
None
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