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EEGDS: Study of neural activity in adults with Down Syndrome - Clinical trials with volunteers - Hospital del Mar Research Institute

Hospital del Mar Research Institute Hospital del Mar Research Institute

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ENDED study

EEGDS: Study of neural activity in adults with Down Syndrome

In animal models of Down's syndrome, it has been shown that there is hyperactivation of the endocannabinoid system and that at the same time there is a greater concentration of endocannabinoids in plasma compared to people with typical intellectual development. Alterations in neural oscillations in people who consume cannabis-derived substances are well described, and we think that the alterations that will be observed in people with Down's syndrome could be similar. We would like to be able to demonstrate this through this study.

The study will require 24 healthy subjects with neurodevelopment considered to be normotypical and 24 subjects with Down's syndrome. An initial health assessment visit must be carried out by means of a clinical interview, taking blood and an electroencephalogram (EEG) to rule out any alterations that interfere with the neural oscillations we want to evaluate in the study, such as epileptic foci.

If a volunteer is selected according to the criteria of the study protocol, they will be assigned a day at the Clinical Research Unit where they will be given three EEGs: one in a resting state and two while performing certain cognitive tasks on a computer or touch-sensitive tablet. This test will record the activity of their brain through waves that will be interpreted by a neurophysiologist. This study involves no treatments, no therapeutic interventions and no follow-up visits.

If you would like to take part, we will do a telephone interview, before you come to the centre, to check that you do not have a disease or take any substances/medication that could interfere with the results of the study, and which are listed in the exclusion criteria.

To take part in the study you will need to have an initial check-up (between 1 and 4 hours) at the Unit, and come back on a different day to take the electroencephalograms (check-in at 8 am and check-out at approximately 4 pm).

The study follows a protocol approved by the PSMAR Drug Research Ethical Committee.

Clinical projects

<p>EEGDS Study</p>

INCLUSION CRITERIA

  • Healthy volunteers with either normotypical development or Down's syndrome
  • Between 18 and 35 years old
  • Weight between 50 and 100 kg
Hospital del Mar Research Institute

Dr. Aiguader, 88, 08003 Barcelona
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Phone: 93 316 04 00 · Fax: 93 316 04 10