DELPHI in Subjects at Risk for Stroke and Dementia
Condition: Stroke; Hypertension; Diabete Mellitus; Dyslipidemias; Sleep Disorder; Smoking; Overweight and Obesity; Familial Alzheimer Disease; Atrial Fibrillation; Cardiac Disease; Cognitive Impairment; Transient Ischemic Attack
MeSH terms: Stroke; Alzheimer Disease; Sleep Wake Disorders; Ischemic Attack, Transient; Atrial Fibrillation; Heart Diseases; Overweight; Dyslipidemias; Diabetes Mellitus
Study type: Observational

Summary: 
      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.
    

Detailed 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:

        1. Definition of DELPHI's average TEP response of at risk for stroke and dementia
           population in subjects over 50-75 years old+/- STD.

        2. Assessing the Safey of the use of DELPHI in at risk for stroke and dementia population.

        3. Defining DELPHI's test-retest reliability by quantifying correlation coefficient between
           two tests.

      Exploratory objectives:

        1. Evaluating the sham stimulation effect.

        2. Assessing confounders effecting results.

      Subjects will perform a medical interview, neurological exam, cognitive evaluations, two
      emotional inventories and a brain MRI scan.
    

Intervention name(s): DELPhI system
Intervention type(s): Device
Intervention description(s): DELPhI software is acquiring and analyzing the TMS evoked response recorded with the EEG.
Other intervention name(s): Transcranial magnetic stimulation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        N= 300 subjects recruited by advertisements or from exsiting database at the ages of 50-75,
        at risk to develop stroke or dementia.