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The DELPhi system is a software device that is used for the noninvasive evaluation of brain plasticity and connectivity. The DELPhi software uses EEG and TMS devices as accessories. Standard electro-physiological acquisition is performed using TMS to evoke regional neuronal potentials measured as EEG data. TMS-EEG data is analyzed with regards to conventional, well established characteristics of neuronal network plasticity and connectivity.
Full description
Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation method that allows to study human cortical function in vivo. Using TMS for examining human cortical functionality is enhanced by combining TMS with simultaneous registration of electroencephalograph (EEG). EEG provides an opportunity to directly measure the cerebral response to TMS. Measuring the cortical TMS Evoked potential (TEP), is used to assess cerebral reactivity across wide areas of neocortex.
By evaluating the propagation of evoked activity in different behavioral states and in different tasks, TMS-EEG has been used to causally probe the dynamic effective connectivity of human brain networks.
In this study the sponsor is intended to collect data of subjects at the ages of 50-75, at risk for stroke and dementia using DELPHI, brain MRI scans, cognitive tests and clinical and demographic information. Some of the patients agreeing to perform a second test will serve for a reliability test.
Primary Objectives:
Exploratory objectives:
Subjects will perform a medical interview, neurological exam, cognitive evaluations, two emotional inventories and a brain MRI scan.
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Inclusion and exclusion criteria
Inclusion criteria:
Male and female at the ages of 50-75 years old (included) with at least one risk factor for Stroke or Dementia* and/or a suspected cognitive impairment**
Willing to cooperate with all study procedures. *Risk factors for Stroke and Dementia:
Previous stroke or TIA
Hypertension
Dyslipidemia
Diabetes Mellitus
Atrial Fibrillation
Other cardiac conditions (such as, MI, Valve disease etc.)
Smoking (any current smokers or past heavy smokers (>20 cigarettes/day)).
Obesity and overweight (BMI>25)
Familial history of dementia
Age ≥ 65
Sleep disturbances
** Suspected cognitive impairment:
self or family report of cognitive impairments
Objective evidence of cognitive impairments
4.2 Exclusion criteria:
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Data sourced from clinicaltrials.gov
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