Clinical trial NCT06731452: Exploring Neurophysiological Markers of Brain Health
Official title: Exploring Markers of Brain Health With EEG and TMS: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Lifestyle
Health-Related Behavior
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 63
Sex: ALL
Minimum age (years): 22
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of DELPHI-MD Output Measures with the online BrainHealth Index
timeFrame: Up to one year
Secondary outcomes:
measure: Correlation of DELPHI-MD Output Measures with Quantitative fMRI Metrics
timeFrame: Up to one year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Center for BrainHealth at The University of Texas at Dallas
state: Texas
Study officials:
affiliation: University of Texas at Dallas
name: Sandra Chapman, PhD
role: PRINCIPAL_INVESTIGATOR
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