Establishment of Delphi-MD Safety Performance and Reliability

A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and reliability for assessment and monitoring of TEP's as neurophysiological measurements.

Safety:

Upper limit of the 95% CI of the device related serious adverse event (SAE) rate is less than or equal to 3.6%

Performance:

Demonstrate differentiation of relevant clinical groups

Reliability:

An acceptable mean Interclass correlation (ICC) statistic (six stimulation) is at least 0.6 Additionally, the within subject variability should be lower than the between subject variability.

Normal Population:

Inclusion criteria

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

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., 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:

Inclusion criteria

• Men and women at the ages of >65
• A clinical diagnosis of Dementia and/or Alzheimer's Disease, Lewy-Body Dementia (DLB), Parkinson's Disease, Normal Pressure Hydrocephalus (NPH) or stroke.

Exclusion criteria

• 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, 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.