Clinical trial NCT03842345: DELPhI Evaluation of Psychiatric Conditions
Official title: Cross-sectional Evaluation of Psychiatric Population With DELPhI- Characterization of Psychiatric Conditions
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Major Depressive Disorder
Bi-Polar Disorder
ADHD
Schizophrenia
OCD
Ptsd
Healthy
Lead sponsor: QuantalX Neuroscience
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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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Primary outcomes:
measure: comparison of DELPhI parameter of Plasticity in psychiatric population to healthy norms.
timeFrame: through study completion, an average of 1 year
measure: comparison of DELPhI parameter of Connectivity in psychiatric population to healthy norms.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: correlation between DELPhI parameters and symptom severity.
timeFrame: through study completion, an average of 1 year
measure: Cluster analysis of Plasticity and connectivity in relation to medical treatment and clinical diagnosis.
timeFrame: through study completion, an average of 1 year.
measure: characterization of the change in Plasticity following change of treatment regimen
timeFrame: through study completion, an average of 1 year.
measure: characterization of the change in Connectivity following change of treatment regimen
timeFrame: through study completion, an average of 1 year.
Other outcomes:
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