DELPhI Evaluation of Psychiatric Conditions

Cross-sectional Evaluation of Psychiatric Population With DELPhI- Characterization of Psychiatric Conditions

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy; Schizophrenia; OCD; ADHD; Major Depressive Disorder; Bi-Polar Disorder; Ptsd

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between DELPhI parameters and symptom severity.	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.	through study completion, an average of 1 year
Cluster analysis of Plasticity and connectivity in relation to medical treatment and clinical diagnosis.	Cluster subjects by each plasticity and connectivity vs. medical treatment and clinical diagnosis.	through study completion, an average of 1 year.
characterization of the change in Plasticity following change of treatment regimen	characterization of the change in Plasticity of Plasticity following change of treatment regimen.	through study completion, an average of 1 year.
characterization of the change in Connectivity following change of treatment regimen	characterization of the change in Connectivity following change of treatment regimen.	through study completion, an average of 1 year.

Collaborators and Investigators

• Sponsor: QuantalX Neuroscience

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depressive Disorder; Schizophrenia; Disease; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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