Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury

Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069795
• Other study ID #: IRB # 1312958125
• Status: Completed
• Phase: N/A
• First received: February 17, 2014
• Last updated: March 14, 2016
• Start date: February 2014
• Est. completion date: August 2014

Study information

• Verified date: March 2016
• Source: Methodist Sports Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 21 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Concussion

Intervention

Other:
• Voice recording

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Methodist Sports Medicine	Waveform Communications LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in formant frequencies	1. Changes in formant frequencies F0,F1,F2,F3 in patients following concussion to recovery time.	2 months	No
Secondary	Changes in duration of speech production	Changes in duration of speech production in patients following concussion to recovery time .	2 months	No