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CompletedNCT02069795Updated Mar 16, 2016

Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury

An interventional study of Voice recording in Concussion, sponsored by Forte Sports Medicine and Orthopedics. Completed. Open to participants aged 6 Years to 21 Years. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by Forte Sports Medicine and Orthopedics · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
6 Years to 21 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Concussion

Keywords

  • concussion, athlete, speech analysis
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 50 is close to the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Forte Sports Medicine and Orthopedics is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients diagnosed or suspected of having a sports concussion seen in a clinical setting
  • Ages 6 -21

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Voice recording

    Subjects voices were recorded as they spoke specific words

    Other: Voice recording

Interventions

  • OtherVoice recording
06

What researchers measure

Primary outcomes

  1. Change in formant frequencies

    1. Changes in formant frequencies F0,F1,F2,F3 in patients following concussion to recovery time.

    Time frame: 2 months

Secondary outcomes

  1. Changes in duration of speech production

    Changes in duration of speech production in patients following concussion to recovery time .

    Time frame: 2 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02069795
Lead sponsor
Forte Sports Medicine and Orthopedics
Collaborators
Waveform Communications LLC
Responsible party
Terry G Horner (Physician, Forte Sports Medicine and Orthopedics) — Principal investigator
First posted
Feb 24, 2014
Start date
Feb 2014
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Mar 16, 2016

Study contacts

Terry G Horner, MD
principal investigator · Forte Sports Medicine and Orthopedics

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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