Early Phase 1
Completed N=4
Assessment of Dystussia in Traumatic Brain Injury
TBI · Brain Injury
Source: ClinicalTrials.gov NCT02240329 ↗
Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Average Urge to Cough (UTC) Following Administration of 200 Micro Mole Capsaicin Solution Concentration — 4.5 Units on a Borg scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Urge to Cough (UTC) Following Administration of 200 Micro Mole Capsaicin Solution Concentration |
4.5 | — |
| PRIMARY Number of Coughs in Response to Stimulation With 200 Micro Moles Capsaicin in Solution |
2.83 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02240329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.