Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury
Primary Purpose
Concussion
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Voice recording
Sponsored by
About this trial
This is an interventional diagnostic trial for Concussion focused on measuring concussion, athlete, speech analysis
Eligibility Criteria
Inclusion Criteria:
- All patients diagnosed or suspected of having a sports concussion seen in a clinical setting
- Ages 6 -21
Exclusion Criteria:
- Patients who have physical injuries to their lips, tongue or oral cavity will be excluded until they have healed.
- Patients with hearing or speech abnormalities who cannot consistently produce the stimulus materials.
- Non-native speakers who cannot read the materials or produce the stimuli consistently.
- Patients who cannot read the materials or produce the stimuli consistently due to their age.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Voice recording
Arm Description
Subjects voices were recorded as they spoke specific words
Outcomes
Primary Outcome Measures
Change in formant frequencies
1. Changes in formant frequencies F0,F1,F2,F3 in patients following concussion to recovery time.
Secondary Outcome Measures
Changes in duration of speech production
Changes in duration of speech production in patients following concussion to recovery time .
Full Information
NCT ID
NCT02069795
First Posted
February 17, 2014
Last Updated
March 14, 2016
Sponsor
Forte Sports Medicine and Orthopedics
Collaborators
Waveform Communications LLC
1. Study Identification
Unique Protocol Identification Number
NCT02069795
Brief Title
Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury
Official Title
Utilization of Speech Analysis as a Diagnostic Tool to Objectively Evaluate Early Signs of Mild Traumatic Brain Injury: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Forte Sports Medicine and Orthopedics
Collaborators
Waveform Communications LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The waveform assessment of an athlete's speech production has a high probability of showing abnormalities after brain injury (concussions) which could be used not only for diagnosis of the concussion, but for recovery of the brain. The aim of this study is to investigate this possibility using the Cobweb automated application system for acoustic processing.
Detailed Description
Concussions affect cognitive and fine muscle motor control, and these changes will be reflected in the acoustic characteristics of the vowels being produced. The methods to identify and analyze the acoustics of vowels will greatly extend the detailed understanding of vowels produced after a concussion. The identification of the changes in formant frequencies, pitch, and duration will provide the means to use these parameters as an automated diagnostic tool. The waveform assessment of the athlete's speech production has a high probability of showing brain abnormalities immediately after a suspected or diagnosed concussion at the venue of the athletic sport. The aim of this study assessment is to investigate this possibility using the Cobweb system and greatly enhance the ability to diagnose a concussion in a timely manner to remove the athlete from practice or play.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion
Keywords
concussion, athlete, speech analysis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Voice recording
Arm Type
Experimental
Arm Description
Subjects voices were recorded as they spoke specific words
Intervention Type
Other
Intervention Name(s)
Voice recording
Primary Outcome Measure Information:
Title
Change in formant frequencies
Description
1. Changes in formant frequencies F0,F1,F2,F3 in patients following concussion to recovery time.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Changes in duration of speech production
Description
Changes in duration of speech production in patients following concussion to recovery time .
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients diagnosed or suspected of having a sports concussion seen in a clinical setting
Ages 6 -21
Exclusion Criteria:
Patients who have physical injuries to their lips, tongue or oral cavity will be excluded until they have healed.
Patients with hearing or speech abnormalities who cannot consistently produce the stimulus materials.
Non-native speakers who cannot read the materials or produce the stimuli consistently.
Patients who cannot read the materials or produce the stimuli consistently due to their age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry G Horner, MD
Organizational Affiliation
Forte Sports Medicine and Orthopedics
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury
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