Exploring the link between mild cognitive impairment and mild traumatic brain injury
Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History
This study is testing if a new brain stimulation treatment can improve memory in people with mild cognitive impairment who have also had a mild traumatic brain injury.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05446584 on ClinicalTrials.gov |
What this trial studies
This study investigates whether biological changes in individuals with amnestic mild cognitive impairment (aMCI) are associated with a history of mild traumatic brain injury (mTBI). Participants will undergo ten study visits, starting with a blood draw and memory evaluation, followed by randomization into one of three conditions of high definition transcranial direct current stimulation (HD-tDCS). Each participant will experience active or sham stimulation over three consecutive days, with memory assessments conducted after each condition. The study aims to understand the effects of HD-tDCS on memory in relation to mTBI history.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older with an active diagnosis of amnestic mild cognitive impairment, with or without a history of mild traumatic brain injury.
Not a fit: Patients with a recent history of mild traumatic brain injury or significant neurological or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved therapeutic strategies for patients with amnestic mild cognitive impairment, particularly those with a history of mild traumatic brain injury.
How similar studies have performed: While the specific combination of HD-tDCS and amnestic mild cognitive impairment is novel, similar studies using HD-tDCS for cognitive enhancement have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Hannah Cabrera, MCRC
- Email: Hannah.Cabrera@utsw.edu
- Phone: 214-865-9508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.