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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if transcranial stimulation, a type of brain stimulation, can assist individuals who struggle to understand one person speaking amidst multiple conversations. The study will evaluate whether this brain stimulation enhances the effectiveness of an auditory training program in improving speech comprehension. Participants will receive either active brain stimulation or a sham (fake) treatment while listening to overlapping conversations. Individuals over 50 who have difficulty understanding speech in noisy settings and have access to a computer or phone with internet may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance speech understanding in noisy environments.

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 transcranial stimulation is safe for improving auditory training?

Research has shown that transcranial stimulation, a type of brain treatment, is generally safe. This method uses small electrical currents on the head to affect brain activity. It has been studied for various conditions, and results suggest it does not seriously harm brain tissue. However, some individuals might experience mild side effects like tingling or skin irritation at the application site.

Other types of transcranial stimulation, such as transcranial magnetic stimulation (TMS), can cause hearing problems if ear protection is not used. In this study, participants will receive transcranial stimulation, so ear protection is unnecessary. This type of stimulation has been used in research without major side effects, but more studies are needed to fully understand any long-term risks. Overall, the treatment is considered safe when used correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial stimulation for hearing loss because it offers a new approach that directly interacts with brain activity. Unlike traditional hearing aids or cochlear implants, which amplify sound or bypass damaged parts of the ear, transcranial stimulation uses electrical currents to enhance the brain's ability to process auditory information. Specifically, this method involves transcranial alternating current stimulation that matches the envelope of the target speech, potentially leading to improved speech perception. This innovative technique could open up new possibilities for individuals who do not benefit from existing treatments.

What evidence suggests that transcranial stimulation is effective for improving speech-on-speech understanding?

Research has shown that transcranial electrical stimulation can help people understand speech better in noisy environments. In this trial, participants will be divided into groups to receive either active transcranial stimulation or sham stimulation. One study demonstrated that combining this brain stimulation with listening exercises helped children with hearing loss hear speech more clearly in noisy settings. Another study found that this method might improve both cognitive skills and hearing in older adults. This brain stimulation sends a gentle electrical current to the scalp, altering nerve function. These early results suggest it could enhance the effectiveness of listening exercises for those who struggle to understand speech amid background noise. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9869764/

Transcranial alternating current stimulation combined with ... We hope to conclude that tACS combined with sound stimulation is safe and tolerable in 87 patients with mild to moderate AD under three ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587624003513

Improve the behavioral auditory attention training effects on ... Conclusion. The study showed that combining auditory attention training with tDCS can improve speech perception in noise for children with hearing loss.

3. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2025.1591496/full

Dual improvement of cognitive function and auditory ability ... Conclusion: Transcranial direct current stimulation-assisted auditory rehabilitation training may improve the cognitive and auditory functions of elderly ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7464917/

Effects of Transcranial Electrical Stimulation on Human ... Transcranial electrical stimulation (tES) can adjust the membrane potential by applying a weak current on the scalp to change the related nerve activity.

5. journals.lww.com journals.lww.com/hbcm/fulltext/2025/07000/transcranial_direct_current_stimulation_in_the.3.aspx

Transcranial direct current stimulation in the treatment of .. ... Our findings demonstrated a statistically significant difference between the real and tDCS groups at 1- and 2-week postintervention for THI scores (P < 0.001).

6. nimh.nih.gov nimh.nih.gov/news/media/2020/sarah-h-lisanby-transcranial-magnetic-stimulation-safety-and-risk

Sarah H. Lisanby: Transcranial Magnetic Stimulation Safety ... TMS does also has a risk of hearing loss, which can be prevented with the proper earplug use for the patient and the operator alike, and we're ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X11000878

Repetitive transcranial magnetic stimulation: Hearing ... The current study showed a small, temporary effect of rTMS noise on cochlear functioning of hearing-protected, healthy young subjects.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... In this review, tDCS safety indicates the absence of a Serious Adverse Effect including brain tissue injury related to tDCS application. It is necessary to ...

9. mayoclinic.org mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

Transcranial magnetic stimulation Hearing loss if the ears aren't well-protected during treatment. More study is needed to determine whether rTMS may have long-term side ...

10. aetna.com aetna.com/cpb/medical/data/400_499/0469.html

Transcranial Magnetic Stimulation and Cranial Electrical ... Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.