Actively Recruiting

Phase Not Applicable
Age: 22Years - 100Years
All Genders
Healthy Volunteers
ID06731452

Exploring Markers of Brain Health With EEG and TMS Using the Delphi-MD Device A Pilot Study

Led by The University of Texas at Dallas · Updated on 2025-09-16

63

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating neurophysiological markers of brain health using a non-invasive brain imaging technique that combines transcranial magnetic stimulation (TMS) and electroencephalography (EEG). This pilot study aims to explore brain health metrics alongside behavioral and functional MRI data collected through a related study called The BrainHealth Project. The investigation focuses on understanding associations between these different types of brain health measures in healthy adults. Participants will undergo brain stimulation using the Direct Electro-Physiological Imaging medical device (Delphi-MD), which delivers magnetic pulses to targeted brain areas while recording the brain's electrical response with EEG. The study involves two in-person sessions aligned with participants' existing imaging appointments, allowing researchers to gather data without additional scheduling burdens. The intervention group also includes online strategic memory and stress management training designed to improve cognitive function and resilience. During the study, participants will complete assessments related to the Delphi-MD output measures, which will be compared with the BrainHealth Index and quantitative fMRI metrics over up to one year. Safety screens for MRI and TMS compatibility are conducted before participation. The research team will monitor brain activity responses and behavioral data to evaluate correlations and better understand brain health. Participants remain involved over the course of these sessions and data collection periods, contributing to advancing brain health research.

CONDITIONS

Brief Title

Exploring Neurophysiological Markers of Brain Health

Who Can Participate

Age: 22Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be an active brain imaging participant in The BrainHealth Project (NCT04869111)
  • Minimum age of 22 years
  • Fluent in English
  • Able to read and hear information over a computer
  • Must pass an MRI safety screener to assess MRI compatibility and other standard Imaging Center requirements
  • Must pass a modified TMS Adult Safety Screen
  • Meet all criteria for study as determined by the study physician
Not Eligible

You will not qualify if you...

  • Diagnosis of a neurodegenerative disease
  • History of stroke, concussion, or brain injury that currently hinders prior level of functioning
  • Diagnosis of autism spectrum disorder that currently hinders independent functioning
  • Metallic brain implants or fragments (e.g., shunt, pacemaker, clips, coils, bullet fragments, cochlear implants)
  • Magnetically activated implants or electronically implanted devices
  • Medication pumps
  • Personal or family history of epilepsy, seizures, or seizure disorder
  • History of or risk factors for syncope (fainting)
  • Significant cognitive challenges
  • Untreated health issues such as substance abuse, hypertension, hypo- or hyper-thyroidism
  • Claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Two sessions over the course of the trial

Participants complete two in-person sessions with the Delphi-MD device that align with their pre-scheduled imaging appointments to receive non-invasive brain stimulation and recording.

2 visits (in-person)

Trial Site Locations

Total: 1 location

1

Center for BrainHealth at The University of Texas at Dallas

Dallas, Texas, United States, 75235

Actively Recruiting

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Research Team

E

Erin Venza, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines.

Simone Rossi, Andrea Antal, Sven Bestmann...

https://pubmed.ncbi.nlm.nih.gov/33243615

Noninvasive brain stimulation with low-intensity electrical currents: putative mechanisms of action for direct and alternating current stimulation.

Soroush Zaghi, Mariana Acar, Brittney Hultgren...

https://pubmed.ncbi.nlm.nih.gov/20040569

Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee.

P M Rossini, D Burke, R Chen...

https://pubmed.ncbi.nlm.nih.gov/25797650

EEG responses to TMS are sensitive to changes in the perturbation parameters and repeatable over time.

Silvia Casarotto, Leonor J Romero Lauro, Valentina Bellina...

https://pubmed.ncbi.nlm.nih.gov/20421968