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WithdrawnNCT03842345Updated Mar 3, 2022

DELPhI Evaluation of Psychiatric Conditions

An observational study in Major Depressive Disorder, Bi-Polar Disorder and ADHD, sponsored by QuantalX Neuroscience. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by QuantalX Neuroscience · Observational

Why this study was withdrawn
Study was withdrawn due to recruitment difficulties
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Depressive Disorder, Major

2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

Browse Depressive Disorder, Major studies →

Lead sponsor

QuantalX Neuroscience is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Psychiatric patients

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

  • healthy controls

    young healthy controls to serve as norm.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 1 year

  2. 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.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. 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.

    Time frame: through study completion, an average of 1 year

  2. 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.

    Time frame: through study completion, an average of 1 year.

  3. characterization of the change in Plasticity following change of treatment regimen

    characterization of the change in Plasticity of Plasticity following change of treatment regimen.

    Time frame: through study completion, an average of 1 year.

  4. characterization of the change in Connectivity following change of treatment regimen

    characterization of the change in Connectivity following change of treatment regimen.

    Time frame: through study completion, an average of 1 year.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03842345
Lead sponsor
QuantalX Neuroscience
Responsible party
Sponsor
First posted
Feb 15, 2019
Start date
Mar 2020 (estimated)
Primary completion
Feb 2021 (estimated)
Completion
Feb 2021 (estimated)
Last update
Mar 3, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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