The Effects of L-carnitine on Fatigue in Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scores (FSS) will be completed by subjects biweekly
研究概览
简要总结
- Purpose: To explore the use of L-Carnitine, a pharmaceutical product, for the treatment of fatigue in persons with spinal cord injury (SCI).
- Hypothesis: Similar to previous research in disabled and aging populations, the investigators hypothesize that treatment with L-Carnitine will result in a significant improvement of clinical fatigue in spinal cord injury clients, effecting a decrease on the Fatigue Severity Scale (FSS) of 0.5 points or more. The investigators expect to see an effect after approximately three weeks of treatment.
As secondary outcomes, the investigators expect to see positive changes in the Centre for Epidemiologic Studies Depression Scale (CES-D)and Visual Analogue Fatigue (VAS-F) and Visual Analogue Pain (VAS-P) scores, due to a combination of previously demonstrated effects of L-Carnitine directly on pain and depression, and the effects of the potential decrease in fatigue.
详细描述
This is a non-concurrent, multiple baseline single subject research design. This pilot study will treat 4 SCI subjects with L-Carnitine, and track the progress of their fatigue prior to, during and following treatment. The target population includes ASIA A, B or C-level SCI subjects at least one year post SCI, with clinically significant fatigue and the ability to provide consent, aged between 19 and 65 years. SCI subjects older than 65 years of age will be excluded due previous research on the effects of L-Carnitine on healthy aging populations. As L-Carnitine has been shown to have positive effects on various effects of aging, these older subjects will be excluded to avoid potentially confounding effects.
Subjects with SCI ASIA A, B or C injuries will be identified from the outpatient list of GF Strong Rehab Centre. Subjects will be initially contacted by letter (letter attached). In addition, recruitment posters will be posted (poster attached). The research coordinator will follow-up by telephone to answer any questions or provide further information about the study, and obtain verbal consent. Given verbal consent, the research coordinator will screen the potential subject for clinically significant fatigue by orally administering the Fatigue Severity Scale. Subjects are required to have an average score of 4 or more on the questions to qualify.
Treatment will consist of the use of 1980 milligrams daily of L-Carnitine over a period of 4 weeks (three 330 mg tablets in the morning and three 330 mg tablets in the evening).
The study is a multiple baseline single subject research design with 4 subjects. Subjects will be randomly assigned to the different baseline lengths.
Subjects will require 4 study visits with interviews. In addition, subjects will be required to complete a daily adverse events log and self-reported bi-weekly outcome measures for the duration of the study. The duration of the study will vary from 10 to 13 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal Cord Injury: paraplegia or tetraplegia (ASIA A, B or C)
- •More than 1 year since date of injury
- •Clinically significant fatigue, determined by a score on the Fatigue Severity Scale greater than or equal to 4
- •Between 19 and 65 years of age
- •Ability to provide informed consent
排除标准
- •Spinal Cord Injury ASIA D, or lack of Spinal Cord Injury
- •Acute phase of rehabilitation: less than 1 year since date of injury
- •Fatigue Severity Scale score less than 4
- •Under 19 years of age or above 65 years of age
- •Inability to provide informed consent
- •Lack of proficiency in English, specified by an inability to read/understand consent form and complete tools
- •Inability to come to GF Strong for 4 separate visits
- •On-going treatment with anticoagulants such as warfarin or acenocoumarol
- •Pregnancy, lactation or breast feeding
- •History of seizures
- •Hypothyroidism
- •Severe liver or kidney disease
- •Other on-going fatigue treatment over the past 6 months
- •On-going treatment with L-carnitine
- •Lack of stability on pain or depression medication over the past 6 months, determined by history. The subjects will be asked about any changes in pain or depression medications over the past 6 months. If they have had a change in pain or depression medications or started a new pain or depression medication within the past 6 months, they will be excluded from the study. Subjects will be asked about their use of supplements and the indications for the supplements. Again, a change in supplements used for pain or depression in the past 6 months will result in exclusion from the study.
研究组 & 干预措施
L-Carnitine
This study has a single subject design. Each subject acts as its own control. All subjects will go through intervention phase (treatment with L-Carnitine).
干预措施: L-Carnitine (Drug)
结局指标
主要结局
Fatigue Severity Scores (FSS) will be completed by subjects biweekly
时间窗: starting from 3,4,5, or 6 weeks following initial visit, will continue throughout the 4 weeks of treatment and for 3 weeks following stop of treatment
次要结局
- Fatigue VAS-F will be completed by subjects biweekly(starting from 3,4,5, or 6 weeks following initial visit, will continue throughout the 4 weeks of treatment and for 3 weeks following cessation of treatment)
- Depression CES-D will be completed by subjects biweekly(starting from 3,4,5, or 6 weeks following initial visit, will continue throughout the 4 weeks of treatment and for 3 weeks following cessation of treatment)
- Pain VAS-P will be completed by subjects biweekly(starting from 3,4,5, or 6 weeks following initial visit, will continue throughout the 4 weeks of treatment and for 3 weeks following cessation of treatment)