Imaging Lymphatic/CSF Drainage From the Head and Neck in Persons With Traumatic Brain Injury: Demonstration of Feasibility and Evaluation of Manual Therapy to Improve Drainage and Facilitate Cognitive Recovery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage
研究概览
简要总结
The purpose of this study is to determine whether a course of daily manual lymphatic drainage over the course of 5 days can improve lymphatic drainage function and cognitive outcomes and to determine whether single sessions of manual lymphatic drainage improves lymphatic drainage in moderate to severe traumatic brain injury (TBI) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female participants must complete the Female Enrollment Form. Those subjects of childbearing potential must have a negative urine pregnancy within 36 hours of study drug administration and also agree to use one of the medically accepted methods of contraception listed on the form for a period of one month following the study. Female subjects of non-childbearing potential, defined as physiologically incapable of becoming pregnant, must meet the criteria listed on the Female Enrollment form, but are not restricted to the use of contraception following study participation.
- •Participants must be able to sit upright for periods of 30 minutes.
- •Participants should have a body mass index between 19 and 30 kg/m2
- •Initial post-resuscitation Glasgow Coma Scale score following blunt head trauma of 3 to 12 or coma (not due to sedation) greater than 6 hours. Emergence from Post-traumatic Amnesia as documented by serial administration of the Orientation-Log or Galveston Orientation and Amnesia Test
- •Have an anticipated hospital length of stay of 5 days or more following screening and consent.
- •Able to provide consent.
排除标准
- •Women who are pregnant or breast-feeding
- •Persons who are known to be allergic to iodine
- •Persons who have extensive soft tissue damage to the neck region, including carotid artery dissection, spinal cord injury, or other conditions, that makes lymphatic drainage techniques undesirable.
- •Women who are of child bearing potential who do not agree to use medically acceptable contraceptives for one month following the study.
- •Subjects who are participating in another interventional trial.
研究组 & 干预措施
Manual Lymphatic Drainage (MLD)
干预措施: Manual Lymphatic Drainage (MLD) (Other)
结局指标
主要结局
change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage
时间窗: day 1, day 5
2 NIRF-LI sessions will be conducted separated by 3 days.
change in cognitive test results as assessed by the learning trial
时间窗: day1,day2,day3,day4,day5
This will be assessed by the number of words participants can remember
Change in processing speed, as assessed by the Wechsler Adult Intelligence Scale -IV
时间窗: day1,day2,day3,day4,day5
Two subtests from the Wechsler Adult Intelligence Scale - IV are used (Coding and Symbol Search). Age-adjusted standard scores are calculated for each of subtest. The 2 subtest scores are then combined to create the Processing Speed Index. Processing Speed Index will be reported as a percentile (0% to 100%), with a higher percentile indicating a better outcome
change in cognitive test results as assessed by the Semantic Category learning trial
时间窗: day1,day2,day3,day4,day5
There are 12 words that participants will categories as Four-legged Animals, precious stones and human dwellings for a total score from 0-12 a higher number indicates a better outcome
change in cognitive test results as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Global health( GH) scale
时间窗: day1,day2,day3,day4,day5
Nine of the 10 PROMIS GH items are scored on a Likert scale from 1 to 5, with 5 representing the best health. Pain which is the 10th question is scored from 0(no pain) to 10(worst imaginable pain).
change in cognitive test results as assessed by the Patient Health Questionnaire-9 (PHQ-9)
时间窗: day1,day2,day3,day4,day5
This scale consists of a set of 9 questions each scored form 0(not at all) to 3 (nearly every day), a higher score indicating a worse outcome. Total score ranges form 0-27.
change in cognitive test results as assessed by the Multilingual Aphasia Examination III-Controlled Oral Word Association
时间窗: day1,day2,day3,day4,day5
This is used to asses phonemic fluency. Participant is asked to name words that begin with a particular letter in one minute and examiner will write down the words said by the participant. This will be reported y the number of words participants say in one minute
change in cognitive test results as assessed by the Trail Making Test(TMT)
时间窗: day1,day2,day3,day4,day5
Scores are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
change in cognitive test results as assessed by the delayed recall trial instructions
时间窗: day1,day2,day3,day4,day5
This will be assessed by the number of words participants can remember after 20-25 minutes delay
次要结局
- Change in NIRF-LI detected lymphatic drainage(day1,day5)
研究者
Eva Sevick
Professor
The University of Texas Health Science Center, Houston