DELPHI in Subjects at Risk for Stroke and Dementia

NCT03884647 | Completed

• 1 other identifier: CL-10-410
• Study Type: observational
• Target: 335
• Locations: 2 countries
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

DELPhI system DEVICE

DELPhI software is acquiring and analyzing the TMS evoked response recorded with the EEG.

Also known as: Transcranial magnetic stimulation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

You may not qualify if:

• 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).
• 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.
• Any contraindication to MRI.
• 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.
• Current ongoing use of opioids, anti-psychotic, or anti-epileptic medications.
• Intake of any other CNS directed medication such as sleeping pills, SSRIs, Anxiolytics 12 hours or less prior to the DELPHI evaluation.
• Subjects that report drug abuse.
• Pregnant or breastfeeding woman.

Sponsors & Collaborators

• QuantalX Neuroscience: lead

Study Sites (4)

Diablo Clinical Research Inc.

Walnut Creek, California, 94598, United States

Location

Neurotrials Research

Atlanta, Georgia, 30328, United States

Location

Clinical Research Center CTI

Norwood, Ohio, 45212, United States

Location

Sourasky Tel-Aviv Medical Center

Tel Aviv, Center, 6492601, Israel

Location

MeSH Terms

Conditions

Stroke; Hypertension; Diabetes Mellitus; Dyslipidemias; Sleep Wake Disorders; Smoking; Overweight; Obesity; Alzheimer Disease; Atrial Fibrillation; Heart Diseases; Cognitive Dysfunction; Ischemic Attack, Transient

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior; Overnutrition; Nutrition Disorders; Body Weight; Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Arrhythmias, Cardiac; Pathologic Processes; Cognition Disorders; Brain Ischemia

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: April 1, 2020
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); IL (1)