Establishment of Delphi-MD Safety Performance and Reliability

NCT06368024 | Completed

• 1 other identifier: CL-12-600
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as neurophysiological measurements.

Conditions

Neurologic Disorder; Healthy

Outcome Measures

Primary Outcomes (3)

• Cortical Excitability

  Amplitude of the TMS Evoked Response (TEP)- Mean amplitude deviation of the entire TEP time frame

  baseline

• Specific Peak Amplitudes

  N45,P60,N100,P180- Amplitudes at corresponding latencies

  baseline

• GMFP

  Global Mean Field Potential- It is a measure of the standard deviation of the potentials across all electrodes, reflecting the overall activity of the brain

  baseline

Interventions

This is a retrospective analysis study of data collected with a diagnostic medical device OTHER

Transcranial Magnetic stimulation and Electroencephalogram

Eligibility Criteria

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

Study Population

Male and Female subjects at the ages of 50-75

You may qualify if:

• Male and female subjects at the ages of 50-75.
• With a technically-eligible EEG-TMS (Delphi-MD) evaluation recording performed

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., Major Depressive Disorder, Generalized Anxiety Disorder, post traumatic stress disorder (PTSD), Bi-polar Disorder, Schizophrenia, Substance abuse),
• Chronic central nervous system (CNS) pain disorders (Migraines, Fibromyalgia).
• 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.
• Record of significant head trauma in the (e.g. loss of consciousness, altered consciousness, diagnosed evidence of contusion on brain imaging following trauma.
• Current ongoing use of opioids, anti-psychotic, anti-epileptic, anti-depressant and Anxiolytics medications.
• Intake of any other CNS directed medication such as sleeping pills 12 hours or less prior to the DELPHI evaluation.
• Subjects that report drug abuse.
• Pregnant or breastfeeding woman.
• Clinical groups:

Sponsors & Collaborators

• QuantalX Neuroscience: lead

Study Sites (1)

QuantalX Neuroscience Ltd.

Kfar Saba, Center, 4453001, Israel

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: April 16, 2024
• Study Start: November 28, 2023
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)