DELPHI in Subjects at Risk for Stroke and Dementia

DELPHI Software for the Analysis of TMS-EEG Data of Brain Functionality - in Subjects at Risk for Stroke and Dementia

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Stroke; Hypertension; Sleep Disorder; Cognitive Impairment; Atrial Fibrillation; Transient Ischemic Attack; Dyslipidemias; Familial Alzheimer Disease; Diabete Mellitus; Overweight and Obesity; Cardiac Disease
• Intervention / Treatment: Device: DELPhI system

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 Type: Observational
• Enrollment (Actual): 335

Contacts and Locations

Study Locations

• Israel
  • Center
    • Tel Aviv, Center, Israel, 6492601
      • Sourasky Tel-Aviv Medical Center
• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • NeuroTrials Research
  • Ohio
    • Norwood, Ohio, United States, 45212
      • Clinical Research Center CTI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion criteria:

1. 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**

2. 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:

1. Any neurodegenerative disease.
2. Neurological developmental disorder (e.g., Cerebral Palsy, Anoxic Brain Damage, Autism Spectrum Disorder).
3. Multiple Sclerosis (MS).
4. Major psychiatric disorders (e.g., PTSD, Bi-polar Disorder, Schizophrenia, Substance abuse),
5. Chronic pain disorders.
6. History of brain tumor, history of brain surgery or brain radiation damage.
7. Prior known epileptic episode.
8. Subjects with any metallic brain implant or fragments (such as shunt, pacemaker, clips, coils, bullet fragments, cochlear implants).
9. Subjects with any implanted devices activated or controlled by physiological signals and/or ferromagnetic or other magnetic sensitive metals implanted in the head or anywhere within 12 inches/30 cm from the stimulation coil.
10. Any contraindication to MRI.
11. With any known significant head trauma in the medical history (e.g. loss of consciousness, altered consciousness, diagnosed evidence of contusion on brain imaging following trauma.
12. Current ongoing use of opioids, anti-psychotic, or anti-epileptic medications.
13. Intake of any other CNS directed medication such as sleeping pills, SSRIs, Anxiolytics 12 hours or less prior to the DELPHI evaluation.
14. Subjects that report drug abuse.
15. Pregnant or breastfeeding woman.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishing DELPhI's norms of population 50-75 years old at risk for stroke and dementia	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.	1 visit
Establish DELPhI's safety in subjects 50-75 at risk for stroke and dementia.	Rates and Frequencies of Adverse events and descriptive report of Adverse events and possible relationship to DELPHI.	1 week
DELPHI's reliability	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.	1 visit

Collaborators and Investigators

• Sponsor: QuantalX Neuroscience

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2020
• Primary Completion (ACTUAL): May 6, 2022
• Study Completion (ACTUAL): May 6, 2022

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (ACTUAL): March 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Endocrine System Diseases; Body Weight; Neurodegenerative Diseases; Arrhythmias, Cardiac; Brain Ischemia; Lipid Metabolism Disorders; Tauopathies; Heart Diseases; Stroke; Diabetes Mellitus; Sleep Wake Disorders; Ischemic Attack, Transient; Atrial Fibrillation; Dementia; Dyslipidemias; Alzheimer Disease; Overweight
• Other Study ID Numbers: CL-10-410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No