Assessment of Dystussia in Traumatic Brain Injury

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: United States Department of Defense
• Treatments: Capsaicin

Criteria

Inclusion Criteria:

1. TBI within 5 years - may have accompanying neck injury but not extensive reconstruction of oral structures.

2. 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.

3. Medical status permits participation.

4. Cognitive status permits participation.

Exclusion Criteria:

1. Refuses consent.

2. Cognitively incapable of informed consent

3. Active substance dependence/use (from clinical interview/record review)

4. Diagnosis of moderate to very severe chronic obstructive pulmonary disease (COPD; from patient interview)

5. History of chronic cough and/or cough syncope (From clinical interview)

6. History of cancer in the head or neck (From clinical interview)

7. History of radiation to the head or neck (From clinical interview)

8. History of stroke or other neurodegenerative disease (From clinical interview) Participants will be enrolled without regard for sex, ethnicity, or age.