Exploring Neurophysiological Markers of Brain Health

The University of Texas System (UT)

Status: Enrolling

Conditions: Healthy Lifestyle; Health-Related Behavior

Treatments: Behavioral: Strategic Memory Advanced Reasoning Training teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance

Study type: Interventional

Funder types: Other

Identifiers

NCT06731452

24-315

Details and patient eligibility

About

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).

Full 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.

Enrollment: 63 estimated patients

Sex: All

Ages: 22 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Online Strategic Memory Advanced Reasoning Training & Stress Solutions

Experimental group

Description:

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.

Treatment:

Behavioral: Strategic Memory Advanced Reasoning Training teaches meta-cognitive strategies for individuals to apply to their daily lives for improved performance