DELPhI Evaluation of Psychiatric Conditions | NCT03842345

Studies
DELPhI Evaluation of Psychiatric Conditions

NCT03842345

Sponsor

QuantalX Neuroscience

Status

Withdrawn

Last Update Posted

Mar 3, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was withdrawn due to recruitment difficulties

Expanded Access Info

Start Date

Mar 2020Estimated

Primary Completion Date

Feb 2021Estimated

Completion Date

Feb 2021Estimated

First Submitted Date

Feb 6, 2019

First Submission Date that Met QC Criteria

Feb 12, 2019

First Posted Date

Feb 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2022

Last Update Posted Date

Mar 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psychiatric patients		Major depression, Bi-polar, schizophrenia, ADHD, OCD, PTSD
healthy controls		young healthy controls to serve as norm.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult male and female patients between the age of 18-80 years old.
Patients willing to participate with all of the study procedures and sign informed consent form.
A clinical diagnosis of psychiatric condition that requires medication or other intervention (such as brain stimulation or psychological treatment).-study groups.
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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D001714	Bipolar Disorder
D001289	Attention Deficit Disorder with Hyperactivity
D012559	Schizophrenia
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided