DELPhI Evaluation of Psychiatric Conditions

• ClinicalTrials.gov Identifier: NCT03842345
• Recruitment Status: Withdrawn
• First Posted: February 15, 2019
• Last Update Posted: March 3, 2022
• Sponsor: QuantalX Neuroscience
• Information provided by (Responsible Party): QuantalX Neuroscience

Study Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 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: March 2020
• Estimated Primary Completion Date: February 2021
• Estimated Study Completion Date: February 2021

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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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Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: QuantalX Neuroscience
• ClinicalTrials.gov Identifier: NCT03842345
• Other Study ID Numbers: 605
• First Posted: February 15, 2019
• Last Update Posted: March 3, 2022
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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