Exploring Neurophysiological Markers of Brain Health

Not Applicable

Recruiting

• Conditions: Healthy Lifestyle; Health-Related Behavior

• Registration Number: NCT06731452
• Lead Sponsor: The University of Texas at Dallas

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).

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.

Study Timeline

• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17
• Study Start: 2025-05-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation of DELPHI-MD Output Measures with the online BrainHealth Index	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 Outcome Measures

Name	Time	Method
Correlation of DELPHI-MD Output Measures with Quantitative fMRI Metrics	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)

Trial Locations

Locations (1)

Center for BrainHealth at The University of Texas at Dallas; 🇺🇸 Dallas, Texas, United States