Visual Evoked Potentials for Hearing Loss

Overseen By Michaela M Geffert, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Brain pathology, Severe neurological disorders, Seizure history, Blindness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment P300 Visually evoked potential, P300, Visual Evoked Potential, VEP for hearing loss?

Research shows that in adults with early-stage hearing loss, visual evoked potentials (VEPs) are larger and faster, indicating that the brain may start using visual processing to compensate for hearing loss. This suggests that VEPs could play a role in understanding and potentially improving outcomes for people with hearing loss. ^{1 2 3 4 5}

Is Visual Evoked Potential (VEP) safe for humans?

Visual Evoked Potentials (VEP) are used in drug development to assess safety and side effects, and they have been applied in neurotoxicity testing for both humans and animals, indicating a general safety profile in these contexts. ^{5 6 7 8 9}

How does the Visual Evoked Potentials treatment differ from other treatments for hearing loss?

The Visual Evoked Potentials treatment is unique because it explores the brain's ability to reorganize itself by using visual processing in areas typically associated with hearing. This approach is different from traditional hearing loss treatments, which usually focus on improving auditory function directly, rather than leveraging visual processing to compensate for hearing deficits. ^{1 2 5 10 11}

Research Team

James E Saunders, MD

Principal Investigator

Department of Surgery, Otolaryngology section, Dartmouth Hitchcock Medical Center

Eligibility Criteria

This trial is for adults over 18 with varying degrees of hearing loss, who are patients or employees at Dartmouth Hitchcock Medical Center (DHMC), or from the local community. It's not for those with blindness, brain tumors, history of strokes, severe neurological issues, seizures, and excludes certain groups like prisoners and minors.

Inclusion Criteria

I am older than 18 years.

People with different levels of hearing loss and difficulty understanding sounds will be asked to join from the ear, nose, and throat clinic at DHMC.

People getting treatment at the DHMC Otolaryngology clinic and those working at Dartmouth College, DHMC, and the community can join if permitted by COVID guidelines.

Exclusion Criteria

Patients with known blindness will be excluded.

I do not have severe brain or nerve disorders.

The following special populations will not be included: Adults unable to consent, Individuals who are not yet adults (infants, children, teenagers), Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Visual Evoked Potential Testing

Participants undergo Visual Evoked Potential testing to measure brain responses to visual stimuli

1 hour

1 visit (in-person)

Auditory and Cognitive Testing

Participants complete auditory tests, cognitive/mood assessments, and cochlear implant sound quality surveys

1-2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

Treatment Details

Interventions

• P300 Visually evoked potential

Trial Overview The study tests if a 'Visual Evoked Potential' measurement can help in treating hearing loss by analyzing the brain's response to visual stimuli. Specifically looking at the P300 wave response after the initial reaction period to see if it can predict successful hearing aid or cochlear implant use.

Participant Groups

Group I: Individuals with Normal Hearing Experimental Treatment 1 Intervention

40 adults (\>18 y/o) without a diagnosis of hearing loss.

Group II: Individuals with Hearing Loss Experimental Treatment 1 Intervention

60 adults (\>18 y/o) with a diagnosis of hearing loss. These participants may use cochlear implant(s), hearing aid(s), or have unaided hearing loss.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Findings from Research

In a study of 43 children with profound sensorineural hearing loss (PSHL), the response rates for ocular and cervical vestibular-evoked myogenic potentials (oVEMP and cVEMP) were significantly lower (58.1% and 61.9%) compared to 100% in healthy children, indicating a potential vestibular dysfunction in these patients.

Despite the observed vestibular dysfunction through VEMPs, neither the children nor their parents reported balance issues, highlighting the importance of using VEMPs as a diagnostic tool to assess hidden otolithic function loss in children with PSHL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The hidden loss of otolithic function in children with profound sensorineural hearing loss. Xu, XD., Zhang, Q., Hu, J., et al.[2020]

Adults with mild-moderate hearing loss exhibited significant changes in visual processing, as indicated by larger visual evoked potential (VEP) amplitudes and altered latencies compared to normal hearing individuals, suggesting early cortical plasticity in response to sensory deprivation.

The study found a correlation between poorer speech perception in noise and decreased N1 VEP latency in hearing-impaired adults, indicating that visual cross-modal re-organization may influence auditory processing and behavioral outcomes in individuals with hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-modal re-organization in adults with early stage hearing loss. Campbell, J., Sharma, A.[2021]

The cortical auditory evoked potential (CAEP), specifically the N1-P2 response complex, serves as an objective and accurate predictor of hearing thresholds in adults and older children, enhancing clinical assessments.

The article discusses various factors affecting CAEP measurements, including maturation and subject characteristics, and provides methods for identifying responses and determining thresholds, demonstrating its utility in clinical and medicolegal contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Summary of the N1-P2 Cortical Auditory Evoked Potential to Estimate the Auditory Threshold in Adults. Lightfoot, G.[2020]

The study found that bimodal listeners showed larger P300 amplitudes and shorter latencies when using both a cochlear implant and a hearing aid compared to using the cochlear implant alone, indicating enhanced auditory processing during bimodal listening.

P300 event-related potentials may reveal benefits of wearing a contralateral hearing aid that behavioral performance measures alone might not capture, suggesting a deeper understanding of auditory processing in bimodal listeners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The P300 auditory event-related potential as a method to assess the benefit of contralateral hearing aid use in bimodal listeners: a proof-of-concept. Van Yper, LN., Dhooge, IJM., Vermeire, K., et al.[2020]

In a study of 29 patients with profound sensorineural hearing loss (PSHL) compared to 20 healthy volunteers, the response rates for ocular and cervical vestibular-evoked myogenic potentials (oVEMP and cVEMP) were significantly lower in patients (38.9% and 44.4%, respectively) than in healthy individuals (100%).

The findings indicate that patients with PSHL exhibit significant dysfunction in otolithic function, as evidenced by higher thresholds and reduced amplitudes in oVEMPs and cVEMPs, suggesting that these tests are valuable for detecting hidden vestibular issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The hidden dysfunction of otolithic organs in patients with profound sensorineural hearing loss. Xu, XD., Ding, CR., Yu, J., et al.[2016]

The authors advocate for using the auditory brainstem response (ABR) as the sole method for ototoxicity testing in nonclinical safety assessments, arguing it is more efficient and less burdensome than including distortion product otoacoustic emissions (DPOAEs).

They emphasize that using both ABR and DPOAEs increases operational challenges and poses health risks to animals due to the need for extended anesthesia, while ABR alone provides sufficient and reliable data for assessing potential auditory harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distortion Product Otoacoustic Emission Test is Not the Test to Use in Nonclinical Safety Assessment. Gauvin, DV., McComb, M., Tapp, R., et al.[2022]

The Brainstem Auditory Evoked Response (BAER) test is a sensitive method for detecting drug-induced hearing loss in safety evaluations, particularly effective in sedated marmosets.

This method not only identifies hearing damage caused by certain drugs but also allows for monitoring recovery if the damage is reversible, making it a potentially superior alternative to traditional reflex testing in drug safety studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening procedure for assessment of ototoxicity in the common marmoset. Kuzel, RA., Smith, JM., Trennery, PN.[2019]

Visual electrophysiological techniques like electroretinography (ERG) and visual evoked potentials (VEP) are valuable tools for assessing the safety and efficacy of new ophthalmic drug therapies during their development and post-marketing phases.

These techniques can objectively measure patient responses to eye medications and detect side effects from non-eye-related drugs, highlighting their importance in monitoring ocular health throughout the drug lifecycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of drug development with special emphasis on the role of visual electrophysiological testing. Brigell, M., Dong, CJ., Rosolen, S., et al.[2018]

Visual evoked potentials (VEPs) in rats can be significantly altered by exposure to various neurotoxic substances, such as heavy metals and pesticides, indicating their potential use in neurotoxicity testing.

Auditory evoked potentials also show sensitivity to neurotoxic chemicals, although the current evidence is limited, suggesting that both VEPs and auditory potentials could be valuable tools for assessing neurotoxicity across species.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological measures of visual and auditory function as indices of neurotoxicity. Otto, D., Hudnell, K., Boyes, W., et al.[2019]

Adults with bilateral postlingual hearing loss show enhanced visual processing in the auditory-associated cortex, indicated by higher P170 and N2 amplitudes and shorter N2 latencies in response to visual stimuli.

This enhanced visual response suggests cortical reorganization in the right frontotemporal area, particularly in the middle frontal gyrus, which may compensate for auditory deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Event-Related Potential Evidence of Enhanced Visual Processing in Auditory-Associated Cortex in Adults with Hearing Loss. Liang, M., Liu, J., Cai, Y., et al.[2021]

The P300 component of visual evoked potentials (VEPs) can provide valuable insights into the subjective visual experiences of patients with functional visual deficits, even when traditional VEPs show normal responses.

In a study of three patients with suspected malingering or hysteria, P300 responses were recorded to stimuli that the patients claimed they could not see, supporting the diagnosis and highlighting the importance of cognitive components in VEP assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosing functional visual deficits with the P300 component of the visual evoked potential. Towle, VL., Sutcliffe, E., Sokol, S.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

The hidden loss of otolithic function in children with profound sensorineural hearing loss. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Cross-modal re-organization in adults with early stage hearing loss. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Summary of the N1-P2 Cortical Auditory Evoked Potential to Estimate the Auditory Threshold in Adults. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The P300 auditory event-related potential as a method to assess the benefit of contralateral hearing aid use in bimodal listeners: a proof-of-concept. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The hidden dysfunction of otolithic organs in patients with profound sensorineural hearing loss. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Distortion Product Otoacoustic Emission Test is Not the Test to Use in Nonclinical Safety Assessment. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Screening procedure for assessment of ototoxicity in the common marmoset. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

An overview of drug development with special emphasis on the role of visual electrophysiological testing. [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

Electrophysiological measures of visual and auditory function as indices of neurotoxicity. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Event-Related Potential Evidence of Enhanced Visual Processing in Auditory-Associated Cortex in Adults with Hearing Loss. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Diagnosing functional visual deficits with the P300 component of the visual evoked potential. [2019]