Clinical trial NCT06368024: Establishment of Delphi-MD Safety Performance and Reliability
Official title: Establishment of Delphi-MD Safety Performance and Reliability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurologic Disorder
Healthy
Lead sponsor: QuantalX Neuroscience
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 263
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and Female subjects at the ages of 50-75

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.

Detailed description: 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.

Eligibility criteria: Normal Population:

Inclusion Criteria:

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

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

Clinical groups:

Inclusion criteria:

1. Men and women at the ages of \>65
2. 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:

1. Subjects with any metallic brain implant or fragments (such as shunt, pacemaker, clips, coils, bullet fragments, cochlear implants).
2. 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.
3. Record of significant head trauma in the (e.g. loss of consciousness, altered consciousness, diagnosed evidence of contusion on brain imaging following trauma.
4. Current ongoing use of opioids, anti-psychotic, or anti-epileptic medications.
5. Intake of any other CNS directed medication such as sleeping pills, SSRIs, Anxiolytics 12 hours or less prior to the DELPHI evaluation.
6. Subjects that report drug abuse.
7. Pregnant or breastfeeding woman.

Primary outcomes:
measure: Cortical Excitability
timeFrame: baseline
measure: Specific Peak Amplitudes
timeFrame: baseline
measure: GMFP
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: QuantalX Neuroscience Ltd.
state: Center
Study officials:
References: