NCT02069795

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

February 17, 2014

Last Update Submit

March 14, 2016

Conditions

Concussion

Keywords

concussion, athlete, speech analysis

Outcome Measures

Primary Outcomes (1)

  • Change in formant frequencies

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

    2 months

Secondary Outcomes (1)

  • Changes in duration of speech production

    2 months

Study Arms (1)

Voice recording

EXPERIMENTAL

Subjects voices were recorded as they spoke specific words

Other: Voice recording

Interventions

Voice recordingOTHER
Voice recording

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Terry G Horner, MD

    Forte Sports Medicine and Orthopedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 24, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 16, 2016

Record last verified: 2016-03