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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
Forte Sports Medicine and Orthopedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Concussion focused on measuring concussion, athlete, speech analysis

Eligibility Criteria

6 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 17, 2014
    Last Updated
    March 14, 2016
    Sponsor
    Forte Sports Medicine and Orthopedics
    Collaborators
    Waveform Communications LLC
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    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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