Neurologic DisorderNCT06368024
Establishment of Delphi-MD Safety Performance and Reliability
An observational study of Neurologic Disorder and Healthy, run by QuantalX Neuroscience at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurologic Disorder, Healthy
- What is being tested?
- This is a retrospective analysis study of data collected with a diagnostic medical device
- How many people
- 263 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Nov 2023to 28 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and Female subjects at the ages of 50-75
Who may be able to join
- Male and female subjects at the ages of 50-75.
- With a technically-eligible EEG-TMS (Delphi-MD) evaluation recording performed
- Men and women at the ages of >65
- A clinical diagnosis of Dementia and/or Alzheimer's Disease, Lewy-Body Dementia (DLB), Parkinson's Disease, Normal Pressure Hydrocephalus (NPH) or stroke.
Who cannot join
- Any neurodegenerative disease.
- Neurological developmental disorder (e.g., Cerebral Palsy, Anoxic Brain Damage, Autism Spectrum Disorder).
- Multiple Sclerosis (MS).
- Major psychiatric disorders (e.g., Major Depressive Disorder, Generalized Anxiety Disorder, post traumatic stress disorder (PTSD), Bi-polar Disorder, Schizophrenia, Substance abuse),
- Chronic central nervous system (CNS) pain disorders (Migraines, Fibromyalgia).
- History of brain tumor, history of brain surgery or brain radiation damage.
Show all 22Show fewer
- Prior known epileptic episode.
- Subjects with any metallic brain implant or fragments (such as shunt, pacemaker, clips, coils, bullet fragments, cochlear implants).
- 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.
- Record of significant head trauma in the (e.g. loss of consciousness, altered consciousness, diagnosed evidence of contusion on brain imaging following trauma.
- Current ongoing use of opioids, anti-psychotic, anti-epileptic, anti-depressant and Anxiolytics medications.
- Intake of any other CNS directed medication such as sleeping pills 12 hours or less prior to the DELPHI evaluation.
- Subjects that report drug abuse.
- Pregnant or breastfeeding woman.
- Clinical groups:
- Subjects with any metallic brain implant or fragments (such as shunt, pacemaker, clips, coils, bullet fragments, cochlear implants).
- 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.
- Record of significant head trauma in the (e.g. loss of consciousness, altered consciousness, diagnosed evidence of contusion on brain imaging following trauma.
- Current ongoing use of opioids, anti-psychotic, or anti-epileptic medications.
- Intake of any other CNS directed medication such as sleeping pills, SSRIs, Anxiolytics 12 hours or less prior to the DELPHI evaluation.
- Subjects that report drug abuse.
- Pregnant or breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neurologic Disorder, Healthy
- Being tested
- This is a retrospective analysis study of data collected with a diagnostic medical device
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a retrospective analysis study of data collected with a diagnostic medical deviceOther
Transcranial Magnetic stimulation and Electroencephalogram
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical Excitability
Amplitude of the TMS Evoked Response (TEP)- Mean amplitude deviation of the entire TEP time frame
Measured: baseline
Specific Peak Amplitudes
N45,P60,N100,P180- Amplitudes at corresponding latencies
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start28 Nov 2023
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- QuantalX Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368024
- Sponsor's protocol ID
- CL-12-600
- Status last verified
- Apr 2024
- First submitted
- 26 Nov 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Delphi-MD Safety Performance and Reliability
- ClinicalTrials.gov ID
- NCT06368024
- Acronym / sponsor ID
- CL-12-600
- Conditions
- Neurologic Disorder, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- QuantalX NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and Female subjects at the ages of 50-75
Key inclusion criteria (4 listed)
- Male and female subjects at the ages of 50-75.
- With a technically-eligible EEG-TMS (Delphi-MD) evaluation recording performed
- Men and women at the ages of >65
- A clinical diagnosis of Dementia and/or Alzheimer's Disease, Lewy-Body Dementia (DLB), Parkinson's Disease, Normal Pressure Hydrocephalus (NPH) or stroke.
Key exclusion criteria (22 listed)
- Any neurodegenerative disease.
- Neurological developmental disorder (e.g., Cerebral Palsy, Anoxic Brain Damage, Autism Spectrum Disorder).
- Multiple Sclerosis (MS).
- Major psychiatric disorders (e.g., Major Depressive Disorder, Generalized Anxiety Disorder, post traumatic stress disorder (PTSD), Bi-polar Disorder, Schizophrenia, Substance abuse),
- Chronic central nervous system (CNS) pain disorders (Migraines, Fibromyalgia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a retrospective analysis study of data collected with a diagnostic medical deviceTranscranial Magnetic stimulation and Electroencephalogram | Other | – |
Primary outcome
Cortical Excitability
Time frame: baseline
Amplitude of the TMS Evoked Response (TEP)- Mean amplitude deviation of the entire TEP time frame
Specific Peak Amplitudes
Time frame: baseline
N45,P60,N100,P180- Amplitudes at corresponding latencies
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Neurologic Disorder
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorder and Healthy, run by QuantalX Neuroscience at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical Excitability (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.