CompletedNot Applicable

DELPHI in Subjects at Risk for Stroke and Dementia

United States, Israel335 participantsStarted 2020-04-01

Plain-language 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.

Who can participate

Age range50 Years – 75 Years

SexALL

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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:

Exclusion criteria

✕. Any neurodegenerative disease.
✕. Neurological developmental disorder (e.g., Cerebral Palsy, Anoxic Brain Damage, Autism Spectrum Disorder).
✕. Multiple Sclerosis (MS).
✕. Major psychiatric disorders (e.g., PTSD, Bi-polar Disorder, Schizophrenia, Substance abuse),
✕. Chronic pain disorders.
✕. History of brain tumor, history of brain surgery or brain radiation damage.
✕. Prior known epileptic episode.
✕. Subjects with any metallic brain implant or fragments (such as shunt, pacemaker, clips, coils, bullet fragments, cochlear implants).

What they're measuring

Establishing DELPhI's norms of population 50-75 years old at risk for stroke and dementia

Timeframe: 1 visit

Establish DELPhI's safety in subjects 50-75 at risk for stroke and dementia.

Timeframe: 1 week

DELPHI's reliability

Timeframe: 1 visit

Trial details

NCT IDNCT03884647

SponsorQuantalX Neuroscience

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-05-06

View on ClinicalTrials.gov More Stroke trials