Intra-Individual Variability in Cognitive Performance as a Marker of Prodromal Disability in MS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cerebral Metabolic Rate of Oxygen (CMRO2)
研究概览
简要总结
The focus of this work is the evaluation of a measure of cognitive functioning- intra-individual variability (IIV) - derived from a computer-based continuous reaction time (RT) task (Cogstate) as an early marker of prodromal MS.
详细描述
This study is a prospective observational clinical study, where the researchers will recruit adults with early MS (n=60) to complete a cognitive assessment and an optional gait assessment using Runscribe and G-sensor. Thirty-five [35] participants will also have a single 60-minute investigational MRI combined with 20 minutes of simultaneous tDCS. The MRI will repeat the protocol from the researchers' current study (ClinicalTrials.gov Identifier: NCT03564496, IRB i18-00548) using simultaneous transcranial direct current stimulation (tDCS) during the imaging acquisition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 23-59 years old (inclusive)
- •Prodromal MS (defined by radiologically isolated syndrome ≤ 6 months from first MRI or clinically isolated syndrome ≤ 3 months from first clinical event)
排除标准
- •Below average estimated premorbid cognitive functioning (based on WRAT-4 reading recognition standard z-score < 85).
- •Presence of severe cognitive impairment (based on SDMT age normative z-score <-3.0).
- •Primary psychiatric disorder that would influence ability to participate.
- •Current uncontrolled seizure disorder.
- •Current substance abuse disorder.
- •History of head trauma in the past year (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator).
- •Pregnant or breastfeeding
- •Additional Exclusion Criteria for tDCS-MRI Participants
- •Extreme claustrophobia
- •Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
- •Treatment for a communicable skin disorder currently or over the past 12 months
- •Have any irremovable piercings, metallic based-tattoos, or MRI-contraindicated implants (e.g. pacemakers and defibrillators)
结局指标
主要结局
Cerebral Metabolic Rate of Oxygen (CMRO2)
时间窗: Day 1 (Visit 1 - approximately 4 minutes)
CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute). To quantify absolute CMRO2, both TRUST MRI for quantification of venous oxygenation (Yv) and phase contrast (PC) MRI for quantification of total blows are needed. The total scan time for CMRO2 MRI is approximately 4 minutes.
Intra-Individual Variability (IIV) as Measured by Cogstate Brief Battery (CBB)
时间窗: Day 1 (Visit 1)
The core Cogstate Reaction Time (RT) tasks involve a deck of cards on a green background screen and the participant answers "yes" or "no" by hitting a keyboard key ("D" or "K") across repeated trials. Each task first includes instructions and practice period before the test begins and takes approximately 3-4 minutes to complete (for a total of \~7 minutes). The representative timed RT scores are provided by the Detection task (indicating when a card is revealed; DET/simple RT), Identification task ("is the card revealed black or red?"; IDN/choice RT), and One-Back ("Is this the card that you just saw?"). Performance is characterized by near complete accuracy (i.e. all, or almost all, items are answered correctly), and validity checks are built into the scoring. IIV is calculated as intraindividual standardized deviations (ISD) in RTs across both tasks, measured in milliseconds and with log10 transformation.
次要结局
- Brief International Cognitive Assessment for MS (BICAMS) Symbol Digit Modalities Test (SDMT) Z-Score(Day 1 (Visit 1))
- BICAMS Rey Auditory Verbal Learning Test (RAVLT) Z-Score(Day 1 (Visit 1))
- BICAMS Brief Visuospatial Memory Test Revised (BVMT-R) Z-Score(Day 1 (Visit 1))