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Healthy LifestyleNCT06731452

Exploring Neurophysiological Markers of Brain Health

A study testing Strategic Memory Advanced Reasoning Training teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance in people with Healthy Lifestyle and Health-Related Behavior, run by The University of Texas at Dallas at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Lifestyle, Health-Related Behavior
What is being tested?
Strategic Memory Advanced Reasoning Training teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteUnited States
Study dates
3 Sep 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Center for BrainHealth at The University of Texas at Dallas

    Dallas, Texas, 75235

    Erin Venza, MS, 972-883-3208, erin.venza@utdallas.edu

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Strategic Memory Advanced Reasoning Training teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called SMART

    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.

Study groups in NCT06731452
Study groupRoleWhat they receive
Online Strategic Memory Advanced Reasoning Training & Stress SolutionsExperimentalStrategic 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.
Receives: Behavioral: Strategic Memory Advanced Reasoning Training teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to one year

Secondary outcomes (1)
  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)

    Measured: Up to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start3 Sep 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731452
Sponsor's protocol ID
24-315
Status last verified
Sep 2026
First submitted
5 Dec 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Strategic Memory Advanced Reasoning Training teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance in people with Healthy Lifestyle and Health-Related Behavior, run by The University of Texas at Dallas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erin Venza, MS (972-883-3208, erin.venza@utdallas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of DELPHI-MD Output Measures with the online BrainHealth Index (time frame: Up to one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06731452, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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