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DELPhI Evaluation of Psychiatric Conditions

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03842345
Enrollment
0
Registered
2019-02-15
Start date
2020-03-31
Completion date
2021-02-28
Last updated
2022-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Bi-Polar Disorder, Healthy, Major Depressive Disorder, OCD, Ptsd, Schizophrenia

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.

Interventions

None listed

Sponsors

QuantalX Neuroscience
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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. \-

Design outcomes

Primary

MeasureTime frameDescription
comparison of DELPhI parameter of Plasticity in psychiatric population to healthy norms.through study completion, an average of 1 yearComparison of DELPhI parameters of Plasticity in patients, in comparison to healthy norms. Parameters will be analyzed for their temporal and special components.
comparison of DELPhI parameter of Connectivity in psychiatric population to healthy norms.through study completion, an average of 1 yearComparison of DELPhI parameters of Connectivity in patients, in comparison to healthy norms. Parameters will be analyzed for their temporal and special components.

Secondary

MeasureTime frameDescription
correlation between DELPhI parameters and symptom severity.through study completion, an average of 1 yearSelf-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.
Cluster analysis of Plasticity and connectivity in relation to medical treatment and clinical diagnosis.through study completion, an average of 1 year.Cluster subjects by each plasticity and connectivity vs. medical treatment and clinical diagnosis.
characterization of the change in Plasticity following change of treatment regimenthrough study completion, an average of 1 year.characterization of the change in Plasticity of Plasticity following change of treatment regimen.
characterization of the change in Connectivity following change of treatment regimenthrough study completion, an average of 1 year.characterization of the change in Connectivity following change of treatment regimen.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026