Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury

NCT ID: NCT02069795

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Concussion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Voice recording

Subjects voices were recorded as they spoke specific words

Group Type EXPERIMENTAL

Voice recording

Intervention Type OTHER

Interventions

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Voice recording

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Waveform Communications LLC

UNKNOWN

Sponsor Role collaborator

Forte Sports Medicine and Orthopedics

OTHER

Sponsor Role lead

Responsible Party

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Terry G Horner

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terry G Horner, MD

Role: PRINCIPAL_INVESTIGATOR

Forte Sports Medicine and Orthopedics

Other Identifiers

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IRB # 1312958125

Identifier Type: -

Identifier Source: org_study_id

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