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DELPhI Software for the Analysis of TMS-EEG Data of Brain Functionality - a Healthy Population Norm Collection Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884647
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
QuantalX Neuroscience

Brief 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. TMS-EEG data is analyzed with regards to conventional, well established characteristics of neuronal network plasticity and connectivity.

Condition or disease Intervention/treatment
Healthy Device: DELPhI (software as a medical device)

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 establish Norms for the DELPhI test by measuring healthy subjects at the ages of 25-45.At this ages, the human brain has finished its normal processes of development and not yet manifest degenerative and hemo-dynamic related deterioration of brain structure. The sponsor will recruit neurologically and psychiatric healthy subjects' cohort to describe the normal distribution of such population. Some of the patients agreeing to perform a second test will serve for a reliability test.

Main objectives:

  1. Definition of DELPhi's healthy population average TEP response in normal, healthy population between the ages 25-45 +/- STD.
  2. Defining DELPhI's test-retest reliability by quantifying correlation coefficient between two tests in young healthy population.

Exploratory objectives:

  1. Evaluating the sham stimulation effect.
  2. Assessing con founders effecting results.

Subjects will perform a medical and neurological evaluation, demographic, State-Trait Anxiety Inventory (STAI) and Difficulties in Emotion Regulation Scale (DERS) questionnaires.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DELPhI Software for the Analysis of TMS-EEG Data of Brain Functionality - a Healthy Population Norm Collection Study
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Intervention Details:
  • Device: DELPhI (software as a medical device)
    DELPhI software is acquiring and analyzing the TMS evoked response recorded with the EEG.
    Other Name: Transcranial magnetic stimulation


Primary Outcome Measures :
  1. Establishing DELPhI's norms of young healthy population. [ Time Frame: through study completion, an average of 1 year ]
    mean, STD, standard error (SEM), coefficient of variation (CV%), minimum, median, maximum and 95% confidence interval for every DELPhI parameter based on the young healthy population normal distribution.

  2. Examining DELPhI's reliability by defining Intra-Class Correlation (ICC) coefficients [ Time Frame: through study completion, an average of 1 year ]
    Examining DELPhI's reliability by defining Intra-Class Correlation (ICC) coefficients between two tests performed 1-30 days apart at each of DELPhI's parameters.



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

N= 200 subjects recruited by advertisements in the clinics and campuses and social media, in the format approved by IRB.

100 subjects will be recruited for the initial part of the study and an additional 100 subjects for the extension study.

Criteria

Inclusion Criteria:

  1. Male and female at the ages of 25-45.
  2. Subjects that declare themselves as healthy.
  3. Willing to cooperate with all study procedures.

Exclusion Criteria:

  1. Subjects that declare any neurological or psychiatric condition or illness in their medical history.
  2. Prior known epileptic episode.
  3. Subjects that receives brain directed medical treatment.
  4. Subjects that report drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884647


Contacts
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Contact: Iftach Dolev, PhD +972-44659491 doleviftach@gmail.com
Contact: Noa Zifman, MSc +972-37553213 noazif@gmail.com

Locations
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Israel
Asaf-Harophe
Rishon LeZion, Israel, 70300
Sponsors and Collaborators
QuantalX Neuroscience
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Responsible Party: QuantalX Neuroscience
ClinicalTrials.gov Identifier: NCT03884647    
Other Study ID Numbers: 0038-19
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No