Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
This research is being done to determine whether a test that measures a "Visual Evoked Potential" can be used in a new way for individuals that have hearing loss. This test measures the participant's brain's response (so called "brain waves") to specific visual images. This study will help the investigators determine whether this test could be used to improve treatments for patients with hearing loss.
The "Visual Evoked Potential" measurement test is already used in the investigator's Neurology clinic at Dartmouth Hitchcock Medical Center for various conditions to measure "early" brain responses that occur in the first 1-2 seconds after a new cue. Our research aims to explore your brain's response just after that early 1-2 second period by looking at a specific response called the "P300". The P300 wave is a brain response to new or different images or sounds. A visual evoked P300 has not been studied in individuals with hearing loss.
The investigators will compare the results of this test to standard auditory tests, tests of cognitive function, and cochlear implant patient outcomes to explore how these factors can predict successful use of a hearing aid or cochlear implant.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects will be recruited from the Otolaryngology/Audiology clinic at DHMC with the goal of enrolling subjects with a variety of degrees of hearing loss and central auditory processing dysfunction.
Age > 18 y/o.
Current and new patients receiving care in the DHMC Otolaryngology clinic or from the employees of Dartmouth College, DHMC, and the community, will be included as allowed under COVID guidelines.
Patients with known brain pathology (e.g., CNS tumors, CVA diagnosis, etc…) will be excluded.
Disqualifiers
None
Trial population
Adults (\>18 y/o) with or without a diagnosis of hearing loss.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
P300 Visually evoked potential
Diagnostic testMeasurement of the late cortical response, P300 potential to visually evoked stimuli using an oddball paradigm.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Individuals with Hearing Loss1 intervention
Group B: Individuals with Normal Hearing1 intervention
Trial outcomes
Primary outcomes
1
Difference in mean VEP latency as measured by onset time of the P300 wave from time of stimuli presentation.
Difference in P300 VEP latency to odd ball paradigm visual stimuli in individuals with hearing loss and normal hearing controls. Differences in VEP latency will be measured by recording onset time of the P300 signal from time of stimuli presentation.
Time frame
30 minutes2
Difference in mean VEP amplitude as measured by the maximum voltage reached by the P300 wave after presentation of stimulus before returning back to zero.
Difference in mean VEP amplitude to odd ball paradigm visual stimuli in individuals with hearing loss and normal hearing controls. Differences in VEP amplitude will be measured by recording maximum voltage reached by the P300 wave after presentation of stimulus before returning back to zero.
Time frame
30 minutesSecondary outcomes
1
Difference in Gap Detection Thresholds as a measure of auditory processing.
Difference in Gap Detection Thresholds between individuals with hearing loss and normal hearing controls. Thresholds (in ms) will be measured and calculated using a software developed by a local engineering company (Creare) in a DHMC Audiology clinic sound booth.
Time frame
15 min2
Difference in cochlear implant sound quality perception as measured by survey responses from participants with cochlear implants.
Participants with cochlear implants will be asked to complete a subjective survey to provide detail about their experience with cochlear implant(s). The survey responses contain both multiple choice answers and continuous rating scales to allow participants to answer questions pertaining to their perception of music, voices, meditative sounds, and general sound perception. The survey is not a scored on a scale, but is instead meant to capture a participant's unique, subjective perception of sound.
Time frame
10 min3
Difference in scores for the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing-impaired individuals (RBANS-H) between individuals with hearing loss and normal hearing controls.
The RBANS-H is a cognitive assessment battery that consists of the 12 following items: List Learning, Story Memory, Figure Copy, Line Orientation, Picture Naming, Semantic Fluency, Digit Span, Coding, List Recall, List Recognition, Story Recall, and Figure Recall. The minimum (worst) RBANS-H score is 0 and the maximum (best) RBANS-H score is 321.
Time frame
45 minutes4
Difference in completion times for the Trail Making Test between individuals with hearing loss and normal hearing controls.
The Trail Making Test is a standard neuropsychological assessment that requires a pen and paper. Part A requires that participants connect randomly placed numbers in ascending order. Part B requires that participants connect randomly placed numbers and letters in alternating numerical/alphabetical order. The Trail Making Test is scored by time (i.e. minutes:seconds). Faster completions of the test are better outcomes than slower completions.
Time frame
5 minSponsors and contacts
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Dartmouth-Hitchcock Medical Center
Lead sponsor
Dartmouth College
Collaborator
Source ClinicalTrials.gov