Establishment of Delphi-MD Safety Performance and Reliability

April 24, 2024 updated by: QuantalX Neuroscience
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
263

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cortical Excitability
Time Frame: baseline
Amplitude of the TMS Evoked Response (TEP)- Mean amplitude deviation of the entire TEP time frame
baseline
Specific Peak Amplitudes
Time Frame: baseline
N45,P60,N100,P180- Amplitudes at corresponding latencies
baseline
GMFP
Time Frame: 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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
QuantalX Neuroscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

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