Establishment of Delphi-MD Safety Performance and Reliability

Completed

• Conditions: Neurologic Disorder; Healthy

• Registration Number: NCT06368024
• Lead Sponsor: QuantalX Neuroscience

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.

Study Timeline

• Study First Submitted: 2023-11-26
• Study Start: 2023-11-28
• Primary Completion: 2023-11-28
• Study Completion: 2023-11-28
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-16
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GMFP	baseline	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
Cortical Excitability	baseline	Amplitude of the TMS Evoked Response (TEP)- Mean amplitude deviation of the entire TEP time frame
Specific Peak Amplitudes	baseline	N45,P60,N100,P180- Amplitudes at corresponding latencies

Trial Locations

Locations (1)

QuantalX Neuroscience Ltd.; 🇮🇱 Kfar Saba, Center, Israel