Exploring Neurophysiological Markers of Brain Health

NCT06731452 | Recruiting

• 1 other identifier: 24-315
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Lifestyle; Health-Related Behavior

Outcome Measures

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)

  Up to one year

Secondary Outcomes (1)

• Correlation of DELPHI-MD Output Measures with Quantitative fMRI Metrics

  Up to one year

Study Arms (1)

Online Strategic Memory Advanced Reasoning Training & Stress Solutions

EXPERIMENTAL

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

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.

Also known as: SMART

Online Strategic Memory Advanced Reasoning Training & Stress Solutions

Eligibility Criteria

• Age: 22 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

Center for BrainHealth at The University of Texas at Dallas

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 33243615 BACKGROUND

• 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.

  PMID: 33796498 BACKGROUND

• 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.

  PMID: 23630469 BACKGROUND

• 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.

  PMID: 20040569 BACKGROUND

• 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.

  PMID: 25797650 BACKGROUND

• Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026.

  PMID: 17640522 BACKGROUND

• 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.

  PMID: 20421968 BACKGROUND

• 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.

  PMID: 18537115 BACKGROUND

• 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.

  PMID: 34526957 BACKGROUND

• 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.

  PMID: 33408607 BACKGROUND

• 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.

  PMID: 34216938 BACKGROUND

• 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.

  PMID: 31551761 BACKGROUND

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sandra Chapman, PhD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Venza, MS

CONTACT

972-883-3208; erin.venza@utdallas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Director of UTD Center for BrainHealth

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 12, 2024
• Study Start: September 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)