Improving Learning in Hispanics With TBI or MS: A Pilot Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Total learning post-treatment (covarying for baseline performance)
研究概览
简要总结
The goal of this study is to establish that a memory retraining protocol, originally developed for English-speakers, and translated into Spanish, is effective.
详细描述
A pilot study will be conducted to carry out this validation and resolve any methodological concerns in the translated protocol. 20 Spanish-speaking Hispanics at least one year post-traumatic brain injury (TBI) and 20 Spanish-speaking Hispanics with multiple sclerosis (MS), both with an objective deficit in learning and memory will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Subjects are randomly assigned to either the experimental or control groups. Experimental and control treatments includes two 45-60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on an objective measure of learning and memory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 18 and 65
- •Spanish is my dominant language, and I have had a traumatic brain injury or I have multiple sclerosis.
排除标准
- •Participants with major depressive disorder, schizophrenia, bipolar disorder I or II
- •MS subjects: Individuals with a history of head injury, stroke, seizures, or any other significant neurological history will not be included in the study.
- •TBI subjects: Individuals must have sustained a TBI at least one year prior to enrollment in the study protocol. Individuals with a history of significant neurological insult other than TBI (e.g. premorbid epilepsy, multiple sclerosis, Alzheimer's disease) will not be included in the study.
研究组 & 干预措施
Spanish mSMT Experimental Treatment
Administered by computer and paper and pencil.
干预措施: Spanish modified Story Memory Technique (mSMT) (Behavioral)
Spanish mSMT Control Treatment
Administered by computer and paper and pencil.
干预措施: Spanish modified Story Memory Technique (mSMT) (Behavioral)
结局指标
主要结局
Total learning post-treatment (covarying for baseline performance)
时间窗: 7 weeks (between pre- and post testing)
Comparison between treatment and control groups on post-treatment Hopkins Verbal Learning Test (HVLT) learning score, covarying for baseline HVLT performance.
次要结局
未报告次要终点
研究者
Denise Krch
Research Scientist
Kessler Foundation