Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury

March 14, 2016 updated by: Terry G Horner, Forte Sports Medicine and Orthopedics

Utilization of Speech Analysis as a Diagnostic Tool to Objectively Evaluate Early Signs of Mild Traumatic Brain Injury: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Voice recording
Subjects voices were recorded as they spoke specific words
Other: Voice recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in formant frequencies
Time Frame: 2 months
1. Changes in formant frequencies F0,F1,F2,F3 in patients following concussion to recovery time.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in duration of speech production
Time Frame: 2 months
Changes in duration of speech production in patients following concussion to recovery time .
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forte Sports Medicine and Orthopedics

Collaborators

Waveform Communications LLC

Investigators

  • Principal Investigator: Terry G Horner, MD, Forte Sports Medicine and Orthopedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (ESTIMATE)

February 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB # 1312958125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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