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DELPhI Evaluation of Psychiatric Conditions

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ClinicalTrials.gov Identifier: NCT03842345
Recruitment Status : Unknown
Verified February 2019 by QuantalX Neuroscience.
Recruitment status was:  Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
QuantalX Neuroscience

Brief Summary:
DELPhI acquisition and analysis software, a QuantalX Neuroscience development, which is designed to measure, analyze, and display brain electrical activity of human electroencephalogram (EEG), to transcranial magnetic stimulation (TMS), will be used to evaluate different psychiatric conditions.

Condition or disease
Major Depressive Disorder Bi-Polar Disorder ADHD Schizophrenia OCD Ptsd Healthy

Detailed Description:
Psychiatric conditions requiring pharmaceutical treatment include Schizophrenia and other psychotic disorders, Major depressive disorder, Bi-polar disorder, Post Traumatic Stress Disorder, Obsessive Compulsive Disorder and anxiety disorders. To date none of the psychiatric conditions mentioned diagnosis' relies on an imaging or other quantitative technique. Diagnosis and treatment prescription in the psychiatric clinic still relies on subjective reports and physician assessment of symptoms. Trans-cranial 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 neo-cortex. Studies integrating TMS with EEG (TMS-EEG) have shown that TMS produces waves of activity that reverberate throughout the cortex. and that are reproducible and reliable thus providing direct information about cortical excitability and connectivity with excellent time resolution. 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cross-sectional Evaluation of Psychiatric Population With DELPhI- Characterization of Psychiatric Conditions
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Group/Cohort
Psychiatric patients
Major depression, Bi-polar, schizophrenia, ADHD, OCD, PTSD
healthy controls
young healthy controls to serve as norm.



Primary Outcome Measures :
  1. comparison of DELPhI parameter of Plasticity in psychiatric population to healthy norms. [ Time Frame: through study completion, an average of 1 year ]
    Comparison of DELPhI parameters of Plasticity in patients, in comparison to healthy norms. Parameters will be analyzed for their temporal and special components.

  2. comparison of DELPhI parameter of Connectivity in psychiatric population to healthy norms. [ Time Frame: through study completion, an average of 1 year ]
    Comparison of DELPhI parameters of Connectivity in patients, in comparison to healthy norms. Parameters will be analyzed for their temporal and special components.


Secondary Outcome Measures :
  1. correlation between DELPhI parameters and symptom severity. [ Time Frame: through study completion, an average of 1 year ]
    Self-control analysis of the change in DELPhI parameters following change in treatment prescription or any other treatment at different time points compared to base-line. Correlation to symptom severity will be assessed.

  2. Cluster analysis of Plasticity and connectivity in relation to medical treatment and clinical diagnosis. [ Time Frame: through study completion, an average of 1 year. ]
    Cluster subjects by each plasticity and connectivity vs. medical treatment and clinical diagnosis.

  3. characterization of the change in Plasticity following change of treatment regimen [ Time Frame: through study completion, an average of 1 year. ]
    characterization of the change in Plasticity of Plasticity following change of treatment regimen.

  4. characterization of the change in Connectivity following change of treatment regimen [ Time Frame: through study completion, an average of 1 year. ]
    characterization of the change in Connectivity following change of treatment regimen.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

study group: patients diagnosed with either Major depression, Bi-polar disorder, OCD, PTSD, ADHD or Schizophrenia,.without any psychiatric medications or with stable treatment regimen for the last 2 months.

Control group:

Eligible consecutive healthy individuals, recruited through advertisements spread in campuses and clinics.

Criteria

Inclusion Criteria:

  1. Adult male and female patients between the age of 18-80 years old.
  2. Patients willing to participate with all of the study procedures and sign informed consent form.
  3. A clinical diagnosis of psychiatric condition that requires medication or other intervention (such as brain stimulation or psychological treatment).-study groups.
  4. Without any psychiatric medications or with stable treatment regimen for the last 2 months-study groups..

4.5. A normal neurological exam- control group.

Exclusion criteria:

1. Prior known epileptic episode. 2. History of any neurodegenerative disease. 3. Patients with history of other known brain disorder/pathology. 4. Contraindication to MR imaging.

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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): NCT03842345


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

Sponsors and Collaborators
QuantalX Neuroscience
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Responsible Party: QuantalX Neuroscience
ClinicalTrials.gov Identifier: NCT03842345    
Other Study ID Numbers: 605
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Disease
Schizophrenia
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Bipolar and Related Disorders