We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02069795
Recruitment Status : Completed
First Posted : February 24, 2014
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
Waveform Communications LLC
Information provided by (Responsible Party):
Terry G Horner, Forte Sports Medicine and Orthopedics

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Concussion Other: Voice recording Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Utilization of Speech Analysis as a Diagnostic Tool to Objectively Evaluate Early Signs of Mild Traumatic Brain Injury: A Pilot Study
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Voice recording
Subjects voices were recorded as they spoke specific words
 Other: Voice recording


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary Outcome Measures :
  1. Changes in duration of speech production [ Time Frame: 2 months ]
    Changes in duration of speech production in patients following concussion to recovery time .


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069795


Sponsors and Collaborators
Forte Sports Medicine and Orthopedics
Waveform Communications LLC
Investigators
Layout table for investigator information
Principal Investigator: Terry G Horner, MD Forte Sports Medicine and Orthopedics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Terry G Horner, Physician, Forte Sports Medicine and Orthopedics
ClinicalTrials.gov Identifier: NCT02069795    
Other Study ID Numbers: IRB # 1312958125
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by Terry G Horner, Forte Sports Medicine and Orthopedics:
concussion, athlete, speech analysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating