Establishment of Delphi-MD Safety Performance and Reliability

Healthy Clinical Trial

Official title:

Establishment of Delphi-MD Safety Performance and Reliability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06368024
• Other study ID #: CL-12-600
• Status: Completed
• Start date: November 28, 2023
• Est. completion date: November 28, 2023

Study information

• Verified date: April 2024
• Source: QuantalX Neuroscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: November 28, 2023
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Nervous System Diseases
• Neurologic Disorder

Intervention

Other:
• This is a retrospective analysis study of data collected with a diagnostic medical device
Transcranial Magnetic stimulation and Electroencephalogram

Locations

Country	Name	City	State
Israel	QuantalX Neuroscience Ltd.	Kfar Saba	Center

Sponsors (1)

Lead Sponsor	Collaborator
QuantalX Neuroscience

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical Excitability	Amplitude of the TMS Evoked Response (TEP)- Mean amplitude deviation of the entire TEP time frame	baseline
Primary	Specific Peak Amplitudes	N45,P60,N100,P180- Amplitudes at corresponding latencies	baseline
Primary	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