Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High Definition Transcranial Direct Current Stimulation.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment, Amnestic Mild Cognitive Disorder, Amnestic Mild Cognitive Impairment, Mild Traumatic Brain Injury. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 fou
Primary outcome measures
- Changes in Rey Auditory Verbal Learning Test Score [Time frame: Baseline and immediately after completion of each HD-tDCS condition]
Secondary outcome measures (2)
- Changes in Delis Kaplan Executive Function System (DKEFS) Trail Making Test [Time frame: Baseline and immediately after completion of each HD-tDCS condition]
- Changes in Delis Kaplan Executive Function System (DKEFS) Color-Word Interference Test [Time frame: Baseline and immediately after completion of each HD-tDCS condition]
Eligibility criteria
Inclusion criteria
- Active diagnosis of amnestic mild cognitive impairment
- Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample
- Female and male subjects
- All races/ethnicities
- Age 55 years and older
- Fluent in English
Exclusion criteria
- Mild traumatic brain injury within past year
- Lifetime history of moderate or severe brain injury
- Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor)
- Lifetime major cardiovascular conditions (e.g., heart attack, heart failure)
- Current substance use disorder
- Current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder)
- Current vision or hearing impairment that interferes with testing
- Any electronic and or metallic implants in the skull or brain
- Current medication use known to alter HD-tDCS reactivity
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT05446584 · STU-2022-0591