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Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History
NCT05446584 · University of Texas Southwestern Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Ten study visits will be completed by each participant. The initial visit will include a blood draw and a baseline memory evaluation. Afterwards, participants will be randomized to begin with one of 3 conditions of HD-tDCS. The three conditions are sham-control, active stimulation to frontal region, and active stimulation to left temporal region. All participants will be expected to completed each HD-tDCS condition, which will be counterbalanced and separated by 14 days. Active HD-tDCS will be applied at 2 mA for 30 minutes over 3 consecutive daily sessions while sham stimulation will be applied for the same duration and timespan. All subjects will complete memory assessments again immediately following each HD-tDCS condition for a total of four test sessions.
Eligibility 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
Study design
Enrollment target: 75 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-04-20
Estimated completion: 2027-05-31
Last updated: 2025-05-04
Interventions
Device: High Definition Transcranial Direct Current Stimulation
Primary outcomes
- • Changes in Rey Auditory Verbal Learning Test Score (Baseline and immediately after completion of each HD-tDCS condition)
Sponsor
University of Texas Southwestern Medical Center · other
Contacts & investigators
ContactHannah Cabrera, MCRC · contact · Hannah.Cabrera@utsw.edu · 214-865-9508
All locations (1)
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States