Clinical trial NCT05446584: Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History
Official title: Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Amnestic Mild Cognitive Disorder
Amnestic Mild Cognitive Impairment
Mild Traumatic Brain Injury
Concussion, Brain
Keywords: MCI
TBI
memory
biomarker
Alzheimer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 75
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects will complete 3 conditions of HD-tDCS. Each HD-tDCS condition is comprised of 3 days of active or sham stimulation targeting the left frontal and temporal lobes (i.e., within-subjects design), randomized by order, and separated by 14 days to avoid carry-over effects.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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

Primary outcomes:
measure: Changes in Rey Auditory Verbal Learning Test Score
timeFrame: Baseline and immediately after completion of each HD-tDCS condition
Secondary outcomes:
measure: Changes in Delis Kaplan Executive Function System (DKEFS) Trail Making Test
timeFrame: Baseline and immediately after completion of each HD-tDCS condition
measure: Changes in Delis Kaplan Executive Function System (DKEFS) Color-Word Interference Test
timeFrame: Baseline and immediately after completion of each HD-tDCS condition
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: