ConcussionNCT02069795
Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury
A study testing Voice recording in people with Concussion, run by Forte Sports Medicine and Orthopedics.
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. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Concussion
- What is being tested?
- Voice recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients diagnosed or suspected of having a sports concussion seen in a clinical setting
- Ages 6 -21
Who cannot join
- 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.
About this study
Official title: 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.
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.
- Conditions
- Concussion
- Being tested
- Voice recording
- Keywords
- concussion, athlete, speech analysis
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice recordingOther
| Study group | Role | What they receive |
|---|---|---|
| Voice recording | Experimental | Subjects voices were recorded as they spoke specific words Receives: Other: Voice recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in formant frequencies
- Changes in formant frequencies F0,F1,F2,F3 in patients following concussion to recovery time.
Measured: 2 months
Secondary outcomes (1)
Changes in duration of speech production
Changes in duration of speech production in patients following concussion to recovery time .
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forte Sports Medicine and Orthopedics
- Sponsor type
- University, hospital or other
- Collaborators
- Waveform Communications LLC
- Responsible party
- Principal investigator, Terry G Horner, Forte Sports Medicine and Orthopedics
- Investigators
- Terry G Horner, MD, Principal investigator, Forte Sports Medicine and Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069795
- Sponsor's protocol ID
- IRB # 1312958125
- Status last verified
- Mar 2016
- First submitted
- 17 Feb 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Speech Analysis as a Diagnostic Tool to Objectively Evaluate Early Signs of Mild Traumatic Brain Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT02069795
- Acronym / sponsor ID
- IRB # 1312958125
- Conditions
- Concussion
- Keywords
- concussion, athlete, speech analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Forte Sports Medicine and OrthopedicsUniversity, hospital or other
- Collaborators
- Waveform Communications LLC
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voice recording | Experimental | Other: Voice recordingSubjects voices were recorded as they spoke specific words |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All patients diagnosed or suspected of having a sports concussion seen in a clinical setting
- Ages 6 -21
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice recording | Other | Voice recording |
Primary outcome
Change in formant frequencies
Time frame: 2 months
1. Changes in formant frequencies F0,F1,F2,F3 in patients following concussion to recovery time.
1 secondary outcome
Changes in duration of speech production
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry G Horner, MD principal investigator
Forte Sports Medicine and Orthopedics
Questions about this trial
What is this clinical trial studying?
A study testing Voice recording in people with Concussion, run by Forte Sports Medicine and Orthopedics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in formant frequencies (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.