DELPHI in Subjects at Risk for Stroke and Dementia

Completed

Conditions studied: Stroke, Hypertension, Diabete Mellitus, Dyslipidemias, Sleep Disorder, Smoking, Overweight and Obesity, Familial Alzheimer Disease, Atrial Fibrillation, Cardiac Disease, Cognitive Impairment, Transient Ischemic Attack

In brief

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.

Key facts

Study ID

NCT03884647

Run by

QuantalX Neuroscience

People needed

335

Starts

2020-04-01

Expected to finish

2022-05-06

Last updated by the study team

2022-09-14

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• 2 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).

Where it is running

• Diablo Clinical Research Inc. — Walnut Creek, California, United States
• Neurotrials Research — Atlanta, Georgia, United States
• Clinical Research Center CTI — Norwood, Ohio, United States
• Sourasky Tel-Aviv Medical Center — Tel Aviv, Center, Israel

Full record on ClinicalTrials.gov

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