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Assessment of Neural Oscillations in Adult Subjects With Down Syndrome and Typically Developing Subjects in Resting State and While Conducting Cognitive Tasks

NCT04791124 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2021-03-10

No results posted yet for this study

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 n=48).

Conditions

  • Down Syndrome

Interventions

OTHER

Electroencephalography

EEG evaluation Composed by three consecutive tests 1. Resting state EEG, with either eyes open or closed 2. Auditory steady-state response (ASSR) 3. Auditory evoked potential

Sponsors & Collaborators

  • Aelis Farma

    collaborator INDUSTRY

  • Starlab

    collaborator UNKNOWN

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Rafael de la Torre Fornell, PharmD, PhD · IMIM (Hospital del Mar Medical Research Institute)

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791124 on ClinicalTrials.gov