Assessment of Dystussia in Traumatic Brain Injury
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Average Urge to Cough (UTC) Following Administration of 200 Micro Mole Capsaicin Solution Concentration
研究概览
简要总结
The purpose of this research study is to evaluate coughing in people who have had a brain injury. It is hypothesized that individuals who have sustained a brain injury will demonstrate differences in cough waveform and respiratory measures compared to individuals who have not sustained a brain injury.
详细描述
Recovery of people with mild, moderate, or severe swallowing, speech, hearing, and cognitive-communication impairments is best facilitated by a team of multidisciplinary specialists. Symptoms associated with traumatic brain injury (TBI) include disordered swallowing (dysphagia), ataxia and, frequently, but not inevitably, dysarthria or disorder of speech. Airway compromise also exists in the form of impaired cough, or dystussia. In view of the frequency of oral intake problems in individuals with TBI and the presence of weakened cough, or absence of cough, along with the added challenge of the cognitive-communicative problems, further studies are needed to increase our understanding of the degree of disordered airway protection. From this work appropriate intervention strategies can be designed along with an understanding of the compensations that may be used to assist with improving swallow and airway safety, oral intake and management.
Informed Consent Process:
Investigators working with subjects with TBI, and who are also aware of this study, will have the ability to provide potential participants with a business card containing only the name of the study coordinator (Dr. Erin Silverman) as well as her email and telephone numbers. The individual participants will be responsible for contacting Dr. Silverman if they wish to participate. Additional participants will be recruited via face to face methods and by the previously IRB-approved study flyer at local brain injury support groups and Shands Rehabilitation Hospital.The staff member consenting (Dr. Silverman) has completed University of Florida training on HIPAA and privacy issues. Subjects do not have to give an immediate response about enrolling and may freely discuss the study with people of their choice before making a decision. Capacity to consent will be decided by the consenting staff member (Dr. Silverman). The study will be explained to the subject, any questions answered, and a written and signed consent completed along with a HIPAA authorization. Written consent will be obtained prior to collection of any health history or study data. Once written informed consent is obtained, Dr. Silverman will conduct an extensive interview in order to insure the subject meets all required inclusionary/exclusionary criteria.
Neuropsychological Testing: The MOCA (Montreal Cognitive Assessment) will be administered by Dr. Silverman, on each participant, upon entry into the study.
Measures of TBI severity: Multiple studies have correlated severity of TBI upon initial admission related to the TBI with swallowing function. The Glasgow Coma Scale (GCS) and Rancho Los Amigos Scale (RLAS) are commonly administered upon admission of TBI patients. When available (availability may vary depending on the hospital at initial admission) we will record the GCS and/or RLAS scores from admission. As well, the investigators will administer the RLAS upon enrollment in the study. These measures will be incorporated into our statistical model to better understand the heterogeneity of cognitive impairment on swallow and cough function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TBI within 5 years - may have accompanying neck injury but not extensive reconstruction of oral structures.
- •Pulmonary function screening: FEV1 >75%, FVC > 75% and FEV1/FVC ratio of >75% of age, sex and ethnicity corrected predicted values, impulse oscillometry R5 resistance measurement within 15% of age, sex and ethnicity corrected predicted values.
- •Medical status permits participation.
- •Cognitive status permits participation.
排除标准
- •Refuses consent.
- •Cognitively incapable of informed consent
- •Active substance dependence/use (from clinical interview/record review)
- •Diagnosis of moderate to very severe chronic obstructive pulmonary disease (COPD; from patient interview)
- •History of chronic cough and/or cough syncope (From clinical interview)
- •History of cancer in the head or neck (From clinical interview)
- •History of radiation to the head or neck (From clinical interview)
- •History of stroke or other neurodegenerative disease (From clinical interview) Participants will be enrolled without regard for sex, ethnicity, or age.
研究组 & 干预措施
Individuals with TBI
Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
干预措施: Neuropsychological Testing and Measures of TBI severity (Behavioral)
Individuals with TBI
Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
干预措施: Respiratory measures (Behavioral)
Individuals with TBI
Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
干预措施: Capsaicin cough sensitivity testing (Drug)
结局指标
主要结局
Average Urge to Cough (UTC) Following Administration of 200 Micro Mole Capsaicin Solution Concentration
时间窗: Day 1
Following 30 seconds of tidal breathing (to allow for acclimation to the facemask), participants were instructed to "take a sharp breath in" whereupon the nebulized capsaicin solution was automatically administered by the dosimeter. Following each aerosol presentation, the participant was instructed to rate their UTC using a modified Borg Rating Scale where 1 = no UTC and 10 = maximum UTC. Between presentations, participants were given a minimum of a one-minute rest period where they were offered water. An average across all measurements was performed for the analysis.
Number of Coughs in Response to Stimulation With 200 Micro Moles Capsaicin in Solution
时间窗: Day 1
The total cough count (CTot) was determined by counting all cough events that occurred following each presentation of capsaicin solution. CTot was made, in real time, by two investigators and confirmed via review of the recorded cough airflow signal. Capsaicin concentration necessary to elicit a two cough threshold response (C2) within 30 seconds of presentation, on at least two (out of three) trials of that concentration, was identified from the cough count record. An average across all measurements was performed for the analysis.
次要结局
未报告次要终点
