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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to understand hearing loss using a test called Visual Evoked Potential (VEP). This test measures brain responses (brain waves) to visual images and could enhance treatments for hearing loss. Researchers aim to determine if these visual brain responses can predict how effectively someone might use a hearing aid or cochlear implant. The trial seeks participants with hearing loss, including those using hearing aids or cochlear implants, as well as individuals with normal hearing. Participants should not have severe neurological issues or a history of seizures. As an unphased study, this trial offers participants the opportunity to contribute to groundbreaking research that could transform future treatments for hearing loss.

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 prior data suggests that the Visual Evoked Potential test is safe for individuals with hearing loss?

Research shows that visual evoked potentials (VEPs), such as the P300, are generally safe. The P300 is a brain wave that occurs when something new or different is seen or heard. Researchers have used it in many studies to understand brain reactions.

Previous studies have used visual evoked potentials in both children and adults without identifying any serious safety issues. For example, one study examined the P300 in individuals with varying levels of hearing loss and found no significant negative effects, suggesting the test is well-tolerated.

The P300 test assesses brain responses without involving invasive procedures, meaning it doesn't enter the body. It is not expected to cause harm, and there are no reports of major side effects. In summary, based on existing research, the P300 visual evoked potential is considered a safe and non-invasive tool. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of using P300 visually evoked potentials to assess hearing loss in a novel way. Most current options for diagnosing hearing loss rely on traditional audiological tests, which primarily focus on sound-based evaluations. However, this approach leverages visual stimuli to evoke brain responses, providing a unique angle by potentially identifying neural processing issues related to hearing. This method could offer a more comprehensive understanding of how the brain processes auditory information, even in those using hearing aids or cochlear implants.

What evidence suggests that the P300 Visual Evoked Potential is effective for hearing loss?

Research shows that the P300 wave, a brain response to new or different sights or sounds, can aid in understanding hearing loss. Studies have found that individuals with hearing loss may exhibit different P300 responses compared to those with normal hearing. This trial will compare participants with hearing loss to those with normal hearing to evaluate these differences. For instance, changes in the P300 response after activating a cochlear implant can indicate improvements in sound processing. Examining P300 responses could enhance the effectiveness of hearing treatments, such as cochlear implants. Although this specific method of studying P300 has not been used with individuals who have hearing loss before, it may provide new insights into how the brain processes sound. ^{1 6 7 8 9}

Who Is on the Research Team?

James E Saunders, MD

Principal Investigator

Department of Surgery, Otolaryngology section, Dartmouth Hitchcock Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9448995/

P300 in individuals with sensorineural hearing loss - PMC The aim of this study was to investigate the auditory evoked potential P300 in individuals with severe to profound congenital hearing loss and to correlate ...

2. pubs.asha.org pubs.asha.org/doi/pdf/10.1044/nsshla_18_121

The Effect of Hearing Loss on the Latency of the P300 ... Fifty instances of the rare stimuli were presented, with test sessions for the evoked responses lasting for approximately 30 minutes. RESULTS. The evoked ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1808869421001828

Is there a change in P300 evoked potential after 6 months ... Lower P3 component latency occurred 6 months after cochlear implant activation with tone-burst and pre-cochlear implant with speech stimulus.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05107466

Quantification of Visually Evoked Cortical Potentials in ... 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 ...

5. withpower.com withpower.com/trial/phase-deafness-9-2021-3cc0d

Visual Evoked Potentials for Hearing Loss 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.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37287098/

The P300 Auditory Evoked Potential: A Physiological ... This study aimed to explore the potential of the P300 (P3b) as a physiological measure of the engagement of cognitive systems contributing to listening effort.

7. mdpi.com mdpi.com/2039-4349/15/1/3

Visual Reliance in Severe Hearing Loss This study aims to study visual evoked potentials (VEPs) in children with severe or profound HL, whether fitted with HAs or CIs.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1808869415303943

Correlation of the P300 evoked potential in depressive and ... In our study we did not see any influence of the degree of hearing loss in the P300 latency. Therefore, peripheral hearing loss does not preclude the use of ...

9. ejo.springeropen.com ejo.springeropen.com/articles/10.1186/s43163-024-00612-6

Assessment of cortical evoked potential (P300) and auditory ... Our results reveal statistically significant variations in the amplitude and latency of the cortical evoked potential (P300) between the post- ...