DELPhI Software for the Analysis of TMS-EEG Data of Brain Functionality - a Healthy Population Norm Collection Study
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|ClinicalTrials.gov Identifier: NCT03884647|
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 27, 2019
|Condition or disease||Intervention/treatment|
|Healthy||Device: DELPhI (software as a medical device)|
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.
- Definition of DELPhi's healthy population average TEP response in normal, healthy population between the ages 25-45 +/- STD.
- Defining DELPhI's test-retest reliability by quantifying correlation coefficient between two tests in young healthy population.
- Evaluating the sham stimulation effect.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
- 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884647
|Contact: Iftach Dolev, PhDemail@example.com|
|Contact: Noa Zifman, MScfirstname.lastname@example.org|
|Rishon LeZion, Israel, 70300|