Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History (NCT05446584) is a Phase 2 interventional studying Mild Cognitive Impairment and Amnestic Mild Cognitive Disorder, sponsored by University of Texas Southwestern Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study will probe if the biological changes in amnestic mild cognitive impairment (aMCI) are related to a history of mild traumatic brain injury (mTBI) using high definition transcranial direct current stimulation (HD-tDCS) and blood-derived biomarker tools. Participants who Do as well as those who Do Not have a history of mTBI will be enrolled in the study.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Mild Cognitive Impairment and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 75 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Mild Cognitive Impairment subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Active diagnosis of amnestic mild cognitive impairment 2. Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample 3. Female and male subjects 4. All races/ethnicities 5. Age 55 years and older 6. Fluent in English Who Should NOT Join This Trial: 1. Mild traumatic brain injury within past year 2. Lifetime history of moderate or severe brain injury 3. Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor) 4. Lifetime major cardiovascular conditions (e.g., heart attack, heart failure) 5. Current substance use disorder 6. Current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder) 7. Current vision or hearing impairment that interferes with testing 8. Any electronic and or metallic implants in the skull or brain 9. Current medication use known to alter HD-tDCS reactivity Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Active diagnosis of amnestic mild cognitive impairment 2. Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample 3. Female and male subjects 4. All races/ethnicities 5. Age 55 years and older 6. Fluent in English Exclusion Criteria: 1. Mild traumatic brain injury within past year 2. Lifetime history of moderate or severe brain injury 3. Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor) 4. Lifetime major cardiovascular conditions (e.g., heart attack, heart failure) 5. Current substance use disorder 6. Current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder) 7. Current vision or hearing impairment that interferes with testing 8. Any electronic and or metallic implants in the skull or brain 9. Current medication use known to alter HD-tDCS reactivity

Treatments Being Tested

DEVICE

High Definition Transcranial Direct Current Stimulation

HD-tDCS for this study is not intended to be a treatment, and will be applied continuously for 30 minutes at sham (0 mA) or 2 mA for active conditions across 3 consecutive daily sessions to probe neural circuit integrity. This specific HD-tDCS device is completely computer driven, running on a laptop using specialized software. Circular electrodes (12-mm in diameter) filled with conductive gel will be placed in a 4x1 ring configuration with the central electrode being the anode surrounded by four cathodes.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Texas Southwestern Medical Center

Dallas, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05446584), the sponsor (University of Texas Southwestern Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05446584 clinical trial studying?

Who can participate in NCT05446584?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05446584?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05446584. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05446584. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.