StrokeNCT03884647
DELPHI in Subjects at Risk for Stroke and Dementia
An observational study of Stroke and Hypertension, run by QuantalX Neuroscience at 4 sites in 2 countries.
Trial summary
The DELPhi system is a software device that is used for the noninvasive evaluation of brain plasticity and connectivity. The DELPhi software uses EEG and TMS devices as accessories. Standard electro-physiological acquisition is performed using TMS to evoke regional neuronal potentials measured as EEG data. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hypertension, Diabete Mellitus
- What is being tested?
- DELPhI system
- Type of treatment
- Medical device
- How many people
- 335 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Apr 2020to 6 May 2022
- 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: N= 300 subjects recruited by advertisements or from exsiting database at the ages of 50-75, at risk to develop stroke or dementia.
Who may be able to join
- Male and female at the ages of 50-75 years old (included) with at least one risk factor for Stroke or Dementia* and/or a suspected cognitive impairment**
- Willing to cooperate with all study procedures. *Risk factors for Stroke and Dementia:
- Previous stroke or TIA
- Hypertension
- Dyslipidemia
- Diabetes Mellitus
Show all 32Show fewer
- Atrial Fibrillation
- Other cardiac conditions (such as, MI, Valve disease etc.)
- Smoking (any current smokers or past heavy smokers (>20 cigarettes/day)).
- Obesity and overweight (BMI>25)
- Familial history of dementia
- Age ≥ 65
- Sleep disturbances
- Suspected cognitive impairment:
- self or family report of cognitive impairments
- Objective evidence of cognitive impairments
- 4.2 Exclusion criteria:
- Any neurodegenerative disease.
- Neurological developmental disorder (e.g., Cerebral Palsy, Anoxic Brain Damage, Autism Spectrum Disorder).
- Multiple Sclerosis (MS).
- Major psychiatric disorders (e.g., PTSD, Bi-polar Disorder, Schizophrenia, Substance abuse),
- Chronic pain disorders.
- History of brain tumor, history of brain surgery or brain radiation damage.
- 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.
- Any contraindication to MRI.
- With any known significant head trauma in the medical history (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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Neurotrials Research
Atlanta, Georgia, 30328
Clinical Research Center CTI
Norwood, Ohio, 45212
Diablo Clinical Research Inc.
Walnut Creek, California, 94598
About this study
Official title: DELPHI Software for the Analysis of TMS-EEG Data of Brain Functionality - in Subjects at Risk for Stroke and Dementia
The DELPhi system is a software device that is used for the noninvasive evaluation of brain plasticity and connectivity. The DELPhi software uses EEG and TMS devices as accessories. Standard electro-physiological acquisition is performed using TMS to evoke regional neuronal potentials measured as EEG data. TMS-EEG data is analyzed with regards to conventional, well established characteristics of neuronal network plasticity and connectivity.
Read the detailed description
Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation method that allows to study human cortical function in vivo. Using TMS for examining human cortical functionality is enhanced by combining TMS with simultaneous registration of electroencephalograph (EEG). EEG provides an opportunity to directly measure the cerebral response to TMS. Measuring the cortical TMS Evoked potential (TEP), is used to assess cerebral reactivity across wide areas of neocortex.
By evaluating the propagation of evoked activity in different behavioral states and in different tasks, TMS-EEG has been used to causally probe the dynamic effective connectivity of human brain networks.
In this study the sponsor is intended to collect data of subjects at the ages of 50-75, at risk for stroke and dementia using DELPHI, brain MRI scans, cognitive tests and clinical and demographic information. Some of the patients agreeing to perform a second test will serve for a reliability test.
Primary Objectives:
- Definition of DELPHI's average TEP response of at risk for stroke and dementia population in subjects over 50-75 years old+/- STD.
- Assessing the Safey of the use of DELPHI in at risk for stroke and dementia population.
- Defining DELPHI's test-retest reliability by quantifying correlation coefficient between two tests.
Exploratory objectives:
- Evaluating the sham stimulation effect.
- Assessing confounders effecting results.
Subjects will perform a medical interview, neurological exam, cognitive evaluations, two emotional inventories and a brain MRI scan.
- Conditions
- Stroke, Hypertension, Diabete Mellitus, Dyslipidemias, Sleep Disorder, Smoking
- Being tested
- DELPhI system
- Medical subject headings
- Stroke, Hypertension, Diabetes Mellitus, Dyslipidemias, Sleep Wake Disorders, Smoking, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DELPhI systemDevice
Also called Transcranial magnetic stimulation
DELPhI software is acquiring and analyzing the TMS evoked response recorded with the EEG.
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing DELPhI's norms of population 50-75 years old at risk for stroke and dementia
Mean, STD, standard error (SEM), coefficient of variation (CV%), minimum, median, maximum and 95% confidence interval, for every DELPHI parameter in at risk for stroke and dementia population.
Measured: 1 visit
Establish DELPhI's safety in subjects 50-75 at risk for stroke and dementia.
Rates and Frequencies of Adverse events and descriptive report of Adverse events and possible relationship to DELPHI.
Measured: 1 week
DELPHI's reliability
Examining DELPHI's reliability by defining Intra-Class Correlation (ICC) coefficients between two tests performed at different days and/or different operators at each of DELPHI's parameters.
Measured: 1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2020
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 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
- NCT03884647
- Sponsor's protocol ID
- CL-10-410
- Status last verified
- Feb 2022
- First submitted
- 19 Mar 2019
- Last updated
- 14 Sep 2022
- Results posted
- 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELPHI Software for the Analysis of TMS-EEG Data of Brain Functionality - in Subjects at Risk for Stroke and Dementia
- ClinicalTrials.gov ID
- NCT03884647
- Acronym / sponsor ID
- CL-10-410
- Conditions
- Stroke, Hypertension, Diabete Mellitus, Dyslipidemias, Sleep Disorder, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- QuantalX NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 21 Mar 2019 (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.
The DELPhi system is a software device that is used for the noninvasive evaluation of brain plasticity and connectivity. The DELPhi software uses EEG and TMS devices as accessories. Standard electro-physiological acquisition is performed using TMS to evoke regional neuronal potentials measured as EEG data. TMS-EEG data is analyzed with regards to conventional, well established characteristics of neuronal network plasticity and connectivity.
Detailed description
Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation method that allows to study human cortical function in vivo. Using TMS for examining human cortical functionality is enhanced by combining TMS with simultaneous registration of electroencephalograph (EEG). EEG provides an opportunity to directly measure the cerebral response to TMS. Measuring the cortical TMS Evoked potential (TEP), is used to assess cerebral reactivity across wide areas of neocortex.
By evaluating the propagation of evoked activity in different behavioral states and in different tasks, TMS-EEG has been used to causally probe the dynamic effective connectivity of human brain networks.
In this study the sponsor is intended to collect data of subjects at the ages of 50-75, at risk for stroke and dementia using DELPHI, brain MRI scans, cognitive tests and clinical and demographic information. Some of the patients agreeing to perform a second test will serve for a reliability test.
Primary Objectives:
- Definition of DELPHI's average TEP response of at risk for stroke and dementia population in subjects over 50-75 years old+/- STD.
- Assessing the Safey of the use of DELPHI in at risk for stroke and dementia population.
- Defining DELPHI's test-retest reliability by quantifying correlation coefficient between two tests.
Exploratory objectives:
- Evaluating the sham stimulation effect.
- Assessing confounders effecting results.
Subjects will perform a medical interview, neurological exam, cognitive evaluations, two emotional inventories and a brain MRI scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- N= 300 subjects recruited by advertisements or from exsiting database at the ages of 50-75, at risk to develop stroke or dementia.
Key inclusion criteria (32 listed)
- Male and female at the ages of 50-75 years old (included) with at least one risk factor for Stroke or Dementia* and/or a suspected cognitive impairment**
- Willing to cooperate with all study procedures. *Risk factors for Stroke and Dementia:
- Any neurodegenerative disease.
- Neurological developmental disorder (e.g., Cerebral Palsy, Anoxic Brain Damage, Autism Spectrum Disorder).
- Multiple Sclerosis (MS).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DELPhI systemAlso: Transcranial magnetic stimulationDELPhI software is acquiring and analyzing the TMS evoked response recorded with the EEG. | Device | – |
Primary outcome
Establishing DELPhI's norms of population 50-75 years old at risk for stroke and dementia
Time frame: 1 visit
Mean, STD, standard error (SEM), coefficient of variation (CV%), minimum, median, maximum and 95% confidence interval, for every DELPHI parameter in at risk for stroke and dementia population.
Establish DELPhI's safety in subjects 50-75 at risk for stroke and dementia.
Time frame: 1 week
Rates and Frequencies of Adverse events and descriptive report of Adverse events and possible relationship to DELPHI.
DELPHI's reliability
Time frame: 1 visit
Examining DELPHI's reliability by defining Intra-Class Correlation (ICC) coefficients between two tests performed at different days and/or different operators at each of DELPHI's parameters.
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 14 Sep 2022.
- Individual participant dataSharing planned: No
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hypertension, run by QuantalX Neuroscience at 4 sites in 2 countries.
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 32 inclusion and 0 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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?
Establishing DELPhI's norms of population 50-75 years old at risk for stroke and dementia (time frame: 1 visit). 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 14 Sep 2022.