Assessment of Dystussia in Traumatic Brain Injury

NCT02240329 | Completed Early Phase 1 Results

• 1 other identifier: 217-2012
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TBI; Brain Injury

Keywords

respiratory; cough

Outcome Measures

Primary Outcomes (2)

• Average Urge to Cough (UTC) Following Administration of 200 Micro Mole Capsaicin Solution Concentration

  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.

  Day 1

• Number of Coughs in Response to Stimulation With 200 Micro Moles Capsaicin in Solution

  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.

  Day 1

Study Arms (1)

Individuals with TBI

OTHER

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.

Behavioral: Neuropsychological Testing and Measures of TBI severity; Behavioral: Respiratory measures; Drug: Capsaicin cough sensitivity testing

Interventions

Neuropsychological Testing and Measures of TBI severity BEHAVIORAL

A brief cognitive assessment will be given to each participant when he or she presents for this project.

Individuals with TBI

Respiratory measures BEHAVIORAL

We will collect measures of cough airflow and breathing strength.

Individuals with TBI

Capsaicin cough sensitivity testing DRUG

Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is.

Also known as: Cough reflex testing

Individuals with TBI

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Silverman E, Sapienza CM, Miller S, Carnaby G, Levy C, Tsai HW, Davenport PW. Preliminary Evidence of Reduced Urge to Cough and Cough Response in Four Individuals following Remote Traumatic Brain Injury with Tracheostomy. Can Respir J. 2016;2016:6875210. doi: 10.1155/2016/6875210. Epub 2016 Sep 27.

  PMID: 27774033 DERIVED

MeSH Terms

Conditions

Brain Injuries; Cough

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Erin Pearson Ph.D CCC/SLP
• Organization: University of Florida

epearson@ufl.edu

352-339-4100

Study Officials

• Paul W Davenport, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: September 15, 2014
• Study Start: March 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 28, 2015
• Results First Posted: October 28, 2015

Record last verified: 2015-09

Locations

US (1)