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

DELPhI Evaluation of Psychiatric Conditions

Sponsors

Lead sponsor: QuantalX Neuroscience

Source 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.

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.

Overall Status Not yet recruiting
Start Date February 2019
Completion Date February 2021
Primary Completion Date February 2021
Study Type Observational
Primary Outcome
Measure Time Frame
comparison of DELPhI parameter of Plasticity in psychiatric population to healthy norms. through study completion, an average of 1 year
comparison of DELPhI parameter of Plasticity in psychiatric population to healthy norms. through study completion, an average of 1 year
comparison of DELPhI parameter of Plasticity in psychiatric population to healthy norms. through study completion, an average of 1 year
comparison of DELPhI parameter of Connectivity in psychiatric population to healthy norms. through study completion, an average of 1 year
comparison of DELPhI parameter of Connectivity in psychiatric population to healthy norms. through study completion, an average of 1 year
comparison of DELPhI parameter of Connectivity in psychiatric population to healthy norms. through study completion, an average of 1 year
Secondary Outcome
Measure Time Frame
correlation between DELPhI parameters and symptom severity. through study completion, an average of 1 year
Cluster analysis of Plasticity and connectivity in relation to medical treatment and clinical diagnosis. through study completion, an average of 1 year.
characterization of the change in 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 through study completion, an average of 1 year.
Enrollment 150
Condition
Eligibility

Sampling method: Non-Probability Sample

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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Gender: All

Minimum age: 18 Years

Maximum age: N/A

Overall Contact

Last name: Iftach Dolev, PhD

Phone: +972-44659491

Email: [email protected]

Verification Date

February 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Psychiatric patients

Description: Major depression, Bi-polar, schizophrenia, ADHD, OCD, PTSD

Arm group label: healthy controls

Description: young healthy controls to serve as norm.

Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov