Exploring Neurophysiological Markers of Brain Health

The University of Texas at Dallas63 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Lifestyle Health-Related Behavior

Interventions

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Eligibility

Sex: ALLMin age: 22 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Center for BrainHealth at The University of Texas at Dallas

Dallas, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

Central Contacts

Erin Venza, MS

CONTACT

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

Data from ClinicalTrials.gov

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