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RecruitingNCT06731452Updated Sep 21, 2026

Exploring Neurophysiological Markers of Brain Health

An interventional study of Strategic Memory Advanced Reasoning Training teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance in Healthy Lifestyle and Health-Related Behavior, sponsored by The University of Texas at Dallas. Recruiting at 1 site in United States. Open to participants aged 22 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
22 Years to 100 Years
Sex
All
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Study summary

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).

Read the detailed description

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.

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Conditions studied

  • Healthy Lifestyle
  • Health-Related Behavior

Browse trials for

03

In context

Health Behavior

967 studies on the registry are indexed under Health Behavior; 165 are open to participants now.

This study's planned enrollment of 63 is below the median of 150 across 824 interventional studies indexed under Health Behavior.

Browse Health Behavior studies →

Lead sponsor

The University of Texas at Dallas is the lead sponsor of 60 studies on the registry; 19 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

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

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Who can participate

Ages eligible
22 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • 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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (estimated)

Study arms

  • Experimental
    Online Strategic Memory Advanced Reasoning Training & Stress Solutions

    Strategic Memory Advanced Reasoning Training (SMART) teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance Stress Solutions provides individuals with opportunities to extend the SMART principles to domains of stress and resilience.

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

Interventions

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

    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.

    Also known as: SMART

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What researchers measure

Primary outcomes

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

    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)

    Time frame: Up to one year

Secondary outcomes

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

    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)

    Time frame: Up to one year

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24. PubMed 33243615 ↗
  • Chapman SB, Fratantoni JM, Robertson IH, D'Esposito M, Ling GSF, Zientz J, Vernon S, Venza E, Cook LG, Tate A, Spence JS. A Novel BrainHealth Index Prototype Improved by Telehealth-Delivered Training During COVID-19. Front Public Health. 2021 Mar 16;9:641754. doi: 10.3389/fpubh.2021.641754. eCollection 2021. PubMed 33796498 ↗
  • Arrenberg AB, Driever W. Integrating anatomy and function for zebrafish circuit analysis. Front Neural Circuits. 2013 Apr 23;7:74. doi: 10.3389/fncir.2013.00074. eCollection 2013. PubMed 23630469 ↗
  • Zaghi S, Acar M, Hultgren B, Boggio PS, Fregni F. Noninvasive brain stimulation with low-intensity electrical currents: putative mechanisms of action for direct and alternating current stimulation. Neuroscientist. 2010 Jun;16(3):285-307. doi: 10.1177/1073858409336227. Epub 2009 Dec 29. PubMed 20040569 ↗
  • Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. 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. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10. PubMed 25797650 ↗
  • Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026. PubMed 17640522 ↗
  • Casarotto S, Romero Lauro LJ, Bellina V, Casali AG, Rosanova M, Pigorini A, Defendi S, Mariotti M, Massimini M. EEG responses to TMS are sensitive to changes in the perturbation parameters and repeatable over time. PLoS One. 2010 Apr 22;5(4):e10281. doi: 10.1371/journal.pone.0010281. PubMed 20421968 ↗
  • Lioumis P, Kicic D, Savolainen P, Makela JP, Kahkonen S. Reproducibility of TMS-Evoked EEG responses. Hum Brain Mapp. 2009 Apr;30(4):1387-96. doi: 10.1002/hbm.20608. PubMed 18537115 ↗
  • Fogel H, Levy-Lamdan O, Zifman N, Hiller T, Efrati S, Suzin G, Hack DC, Dolev I, Tanne D. Brain Network Integrity Changes in Subjective Cognitive Decline: A Possible Physiological Biomarker of Dementia. Front Neurol. 2021 Aug 30;12:699014. doi: 10.3389/fneur.2021.699014. eCollection 2021. PubMed 34526957 ↗
  • Levy-Lamdan O, Zifman N, Sasson E, Efrati S, Hack DC, Tanne D, Dolev I, Fogel H. Evaluation of White Matter Integrity Utilizing the DELPHI (TMS-EEG) System. Front Neurosci. 2020 Dec 21;14:589107. doi: 10.3389/fnins.2020.589107. eCollection 2020. PubMed 33408607 ↗
  • Maidan I, Zifman N, Hausdorff JM, Giladi N, Levy-Lamdan O, Mirelman A. A multimodal approach using TMS and EEG reveals neurophysiological changes in Parkinson's disease. Parkinsonism Relat Disord. 2021 Aug;89:28-33. doi: 10.1016/j.parkreldis.2021.06.018. Epub 2021 Jun 29. PubMed 34216938 ↗
  • Zifman N, Levy-Lamdan O, Suzin G, Efrati S, Tanne D, Fogel H, Dolev I. Introducing a Novel Approach for Evaluation and Monitoring of Brain Health Across Life Span Using Direct Non-invasive Brain Network Electrophysiology. Front Aging Neurosci. 2019 Sep 9;11:248. doi: 10.3389/fnagi.2019.00248. eCollection 2019. PubMed 31551761 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Dec 2027, 27 months after the start.

Of 567 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 27 months is above that.

Counting every sponsor, half of 585 studies reached it within 15 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2024
First posted
Dec 12, 2024
StartActual
Sep 3, 2025
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, 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
NCT06731452
Lead sponsor
The University of Texas at Dallas
Responsible party
Sandra Chapman, PhD (Professor, Chief Director of UTD Center for BrainHealth, The University of Texas at Dallas) — Principal investigator
First posted
Dec 12, 2024
Start date
Sep 3, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Erin Venza, MS
Contact
erin.venza@utdallas.edu
972-883-3208
Sandra Chapman, PhD
principal investigator · The University of Texas at Dallas

Oversight

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

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