Transcranial Stimulation + Auditory Training for Hearing Loss

Overseen By Elin Roverud, AuD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Non-native English, Neurological disorders, others

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

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

94 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if non-invasive brain stimulation (called transcranial stimulation) can enhance the benefits from auditory training in people who struggle to understand one talker when many people are talking at the same time. The main questions it aims to answer are: * Does transcranial stimulation improve speech-on-speech understanding in people who struggle with this task? * Does transcranial stimulation enhance the benefits of a commercially available auditory training program? Researchers will compare transcranial stimulation to sham stimulation (no stimulation is applied during the listening task). Participants will: * Receive login information to an online auditory training program to complete at home over 2 weeks * Visit the laboratory 4 times to receive transcranial stimulation while listening to speech-on-speech: once before at-home training, two times during the at-home training period, and once after at-home training has ended

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 Transcranial Stimulation for hearing loss?

A case report showed that transcranial direct current stimulation (tDCS) over the auditory cortex improved speech discrimination in a patient with hearing impairment after brainstem encephalitis, suggesting potential benefits for hearing loss. ^{1 2 3 4 5}

Is transcranial stimulation safe for humans?

Research suggests that transcranial stimulation, including transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), is generally safe for humans. Studies have shown no significant adverse effects on hearing function in healthy subjects, but monitoring auditory functions in future trials is recommended. ^{3 6 7 8 9}

How does the treatment of Transcranial Stimulation + Auditory Training for Hearing Loss differ from other treatments?

This treatment is unique because it combines transcranial stimulation, which can enhance brain activity in the auditory cortex, with auditory training to improve hearing. Unlike traditional hearing aids that amplify sound, this approach aims to directly modify brain function to improve speech perception and sound localization. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals with hearing loss, specifically those who have difficulty understanding speech in noisy environments. Participants will need to complete an auditory training program at home and visit a lab four times for transcranial stimulation sessions.

Inclusion Criteria

I am 50 years old or older.

I have trouble understanding speech when there is background noise.

Able to read print on a computer screen

Exclusion Criteria

English is not my first language.

History of skull fracture, scalp tissue damage, metallic implants around the head, seizures, neurological disorders, or traumatic brain injury, current or suspected pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive transcranial stimulation and auditory training over a 2-week period

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcranial Stimulation

Trial Overview The study tests if transcranial stimulation can improve the ability to understand one person talking when there's background noise. It also examines whether this brain stimulation boosts the effects of an auditory training program compared to sham (fake) stimulation.

Participant Groups

Group I: Active transcranial stimulation Experimental Treatment 2 Interventions

This group will receive active transcranial alternating current stimulation that matches the envelope of the target speech.

Group II: Sham stimulation Placebo Group 1 Intervention

This group will receive transcranial stimulation that ramps on and off before the speech is presented.

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Findings from Research

A formal auditory training program significantly improved behavioral aspects of auditory function in seven adults aged 46 to 57 with bilateral high-frequency hearing loss, particularly in understanding speech in noisy environments.

While some electrophysiological measures showed no significant change, the training led to the emergence of previously absent long-latency components in some participants, indicating potential neural adaptations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of auditory training in individuals with high-frequency hearing loss. Santos, RB., Marangoni, AT., de Andrade, AN., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The advantages of sound localization and speech perception of bilateral electric acoustic stimulation. [2018]

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

Anatomical and Functional MRI Changes after One Year of Auditory Rehabilitation with Hearing Aids. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Anodal transcranial direct current stimulation over the auditory cortex improved hearing impairment in a patient with brainstem encephalitis. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Cross-modal plasticity in developmental and age-related hearing loss: Clinical implications. [2022]

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

Effects of auditory training in individuals with high-frequency hearing loss. [2022]

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

Neuromodulation of Right Auditory Cortex Selectively Increases Activation in Speech-Related Brain Areas in Brainstem Auditory Agnosia. [2019]

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

Effect of 1 Hz repetitive transcranial magnetic stimulation over the auditory cortex on audiometry and otoacustic emissions. [2012]

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

Can theta burst stimulation safely influence auditory hearing thresholds in healthy young adults? [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Excitability changes induced in the human auditory cortex by transcranial direct current stimulation: direct electrophysiological evidence. [2021]