Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Changes in Rey Auditory Verbal Learning Test Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The subjects will be informed that sham and active HD-tDCS will be used in the study, but they will be masked to condition. Aside from the PI, other study team members who perform assessments will be masked to HD-tDCS condition.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active left frontal HD-tDCS
Electrodes will be placed in a 4x1 ring configuration over the frontal region in accordance with the International 10-10 EEG system. Stimulation will consist of a ramp up period in which the electrical current is gradually increased, 30 minutes of stimulation at 2 mA, and a ramp down period during which the electrical current is gradually removed. Stimulation will be applied back-to-back over three consecutive days.
干预措施: High Definition Transcranial Direct Current Stimulation (Device)
Active left temporal HD-tDCS
Electrodes will be placed in a 4x1 ring configuration over the left temporal region in accordance with the International 10-10 EEG system. Stimulation will consist of a ramp up period in which the electrical current is gradually increased, 30 minutes of stimulation at 2 mA, and a ramp down period during which the electrical current is gradually removed. Stimulation will be applied back-to-back over three consecutive days.
干预措施: High Definition Transcranial Direct Current Stimulation (Device)
Sham HD=tDCS
Electrodes will be placed in the same 4x1 ring configuration over the frontal region as the active left frontal condition to ensure a useful control condition. Stimulation will consist of a 30-second ramp up period until reaching 2 mA, followed immediately by a 30-second ramp down, and off for 29 minutes. The same ramp up and down process will be repeated in the final minute of the session to help preserve masking of conditions. Sham stimulation will be applied back-to-back over three consecutive days.
干预措施: High Definition Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Changes in Rey Auditory Verbal Learning Test Score
时间窗: Baseline and immediately after completion of each HD-tDCS condition
The RAVLT is a verbal episodic memory test that is sensitive to mesial and lateral verbal episodic memory circuit dysfunction. The primary outcome measure for this task is the total number of items immediately recalled during the learning trials and after the 20 minute delayed recall trial. Changes in scores from baseline to testing immediately following the completion of each condition will be examined.
次要结局
- Changes in Delis Kaplan Executive Function System (DKEFS) Trail Making Test(Baseline and immediately after completion of each HD-tDCS condition)
- Changes in Delis Kaplan Executive Function System (DKEFS) Color-Word Interference Test(Baseline and immediately after completion of each HD-tDCS condition)
研究者
Christian Lobue
Associate Professor
University of Texas Southwestern Medical Center