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 performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as neurophysiological measurements.

Study Overview

• Status: Completed
• Conditions: Healthy; Neurologic Disorder
• Intervention / Treatment: Other: This is a retrospective analysis study of data collected with a diagnostic medical device

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 Type: Observational
• Enrollment (Actual): 263

Contacts and Locations

Study Locations

• Israel
  • Center
    • Kfar Saba, Center, Israel, 4453001
      • QuantalX Neuroscience Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Male and Female subjects at the ages of 50-75

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: QuantalX Neuroscience

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Actual): November 28, 2023
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: November 26, 2023
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: CL-12-600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No