DELPHI in Subjects at Risk for Stroke and Dementia

Completed

• Conditions: Stroke; Sleep Disorder; Dyslipidemias; Familial Alzheimer Disease; Hypertension; Diabete Mellitus; Overweight and Obesity; Cognitive Impairment; Smoking; Atrial Fibrillation

• Registration Number: NCT03884647
• Lead Sponsor: QuantalX Neuroscience

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Study Start: 2020-04-01
• Status Verified: 2022-02
• Primary Completion: 2022-05-06
• Study Completion: 2022-05-06
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishing DELPhI's norms of population 50-75 years old at risk for stroke and dementia	1 visit	Mean, STD, standard error (SEM), coefficient of variation (CV%), minimum, median, maximum and 95% confidence interval, for every DELPHI parameter in at risk for stroke and dementia population.
Establish DELPhI's safety in subjects 50-75 at risk for stroke and dementia.	1 week	Rates and Frequencies of Adverse events and descriptive report of Adverse events and possible relationship to DELPHI.
DELPHI's reliability	1 visit	Examining DELPHI's reliability by defining Intra-Class Correlation (ICC) coefficients between two tests performed at different days and/or different operators at each of DELPHI's parameters.

Trial Locations

Locations (4)

Neurotrials Research; 🇺🇸 Atlanta, Georgia, United States

Diablo Clinical Research Inc.; 🇺🇸 Walnut Creek, California, United States

Clinical Research Center CTI; 🇺🇸 Norwood, Ohio, United States

Sourasky Tel-Aviv Medical Center; 🇮🇱 Tel Aviv, Center, Israel