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NCT Number: NCT06731452

Exploring Neurophysiological Markers of Brain Health

The combination of transcranial magnetic stimulation (TMS) and electroencephalography (EEG) has been suggested as a promising brain imaging tool for identifying biomarkers of brain health.

In this pilot study, study investigators will explore the neurophysiological metrics of brain health with a non-invasive brain imaging technique, alongside behavioral and fMRI metrics collected through another study (NCT04869111).

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Key information

Age range

22 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for BrainHealth at The University of Texas at Dallas

Dallas, Texas, 75235, United States

Location status: Recruiting

Location contact

Erin Venza, MS

CONTACT

[email protected]

972-883-3208

About this study

The Direct Electro-Physiological Imaging medical device (Delphi-MD), developed by QuantalX Neuroscience, combines both TMS and EEG technologies. This is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in participants, and the EEG device records brain electrophysiological response to the stimulation.

Recruitment for this pilot study will be restricted to participants in the imaging cohort of a separate study, The BrainHealth Project (NCT04869111). As that cohort is already completing behavioral and fMRI metrics, this exploratory study would allow study investigators to examine relevant associations between those metrics with the neurophysiological metrics from the Delphi device.

Study participants will complete two in-person sessions with the Delphi-MD device that align with their pre-scheduled imaging appointments.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be an active brain imaging participant in The BrainHealth Project (NCT04869111)
  • Minimum age of 22
  • Fluent in English
  • Able to read & hear information over a computer
  • Must pass an MRI safety screener to assess the presence of contraindicators for MRI compatibility (i.e., non-removable metal within/on the body, claustrophobia, pregnancy, non-correctable vision problems, head trauma, and CNS disease)or other standard requirements as determined by the Imaging Center.
  • Must pass a modified TMS Adult Safety Screen
  • Meet all criteria for study as determined by the study physician

Exclusion criteria

  • A diagnosis of a neurodegenerative disease
  • A history of stroke, concussion, or brain injury that currently hinders them from functioning at their prior level
  • A diagnosis of autism spectrum disorder that currently hinders them from functioning independently.
  • Metallic brain implants or fragments (like a shunt, pacemaker, clips, coils, bullet fragments, cochlear implants)
  • Magnetically activated implants or electronically implanted devices
  • Medication pumps
  • Personal or family history of epilepsy, seizure(s), seizure disorder.
  • History of, or risk factors for syncope (fainting)
  • Report significant cognitive challenges
  • Report untreated health issues (like substance abuse, hypertension, hypo- or hyper-thyroidism)
  • Have claustrophobia

Treatment and study plan

Strategic Memory Advanced Reasoning Training teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance

Behavioral

Online SMART is a curriculum that teaches strategies of how to use the brain better, in such a way that may improve brain health and performance. SMART strives to achieve optimal cognitive function realized by the brain's ability to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize details, and to prioritize the information in order to attend to the most relevant parts.

Stress Solutions extends the SMART principles to relevant domains of stress and resilience.

Other names: SMART

Primary outcomes

  1. Correlation of DELPHI-MD Output Measures with the online BrainHealth Index

    Time frame: Up to one year

    Evaluate the strength and significance of correlations between DELPHI-MD output metrics (e.g., cortical excitability, local/global mean field potentials, response amplitude, and latency) and scores from the BrainHealth Index. Unit of Measurement: Correlation coefficient (r).

    (Minimum value: -1.0, Maximum value: 1.0) (Higher value represents stronger correlation)

Secondary outcomes

  1. Correlation of DELPHI-MD Output Measures with Quantitative fMRI Metrics

    Time frame: Up to one year

    Assess the relationships between DELPHI-MD output metrics and the following fMRI metrics collected in separate study (i) functional connectivity, (ii) cerebral blood flow, (iii) cerebrovascular reactivity, and (iv) white matter integrity. Unit of Measurement: Correlation coefficient (r).

    (Minimum value: -1.0, Maximum value: 1.0) (Higher value represents stronger correlation)

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Venza, MS

CONTACT

[email protected]

972-883-3208

Sponsors and collaborators

Lead sponsor

The University of Texas at Dallas

Other

Registry information

Official study title

Exploring Markers of Brain Health With EEG and TMS: A Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 12, 2024
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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