Neuromodulation and Listening Therapy for Tinnitus

(TDCS Trial)

Overseen By Barbara Cone, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Neurological disorders, Epilepsy, Meniere's, others

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

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with tinnitus (ringing in the ears) and hyperacusis (sensitivity to everyday sounds) by combining brain stimulation and listening therapy. The brain stimulation, known as transcranial direct current stimulation (tDCS), is a non-invasive technique that applies gentle electrical currents to the head. Participants will receive either the active treatment or a sham (inactive) version, along with active listening therapy. Individuals who have experienced tinnitus or hyperacusis for more than 8 months and find it affects their daily life may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatment methods for those seeking relief from these conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that transcranial direct current stimulation (tDCS) and active listening therapy are safe for treating tinnitus?

Research shows that both Active Listening Therapy and transcranial Direct Current Stimulation (tDCS) have been studied for their safety in people.

Studies on Active Listening Therapy indicate it can reduce tinnitus symptoms without serious side effects. Participants reported their tinnitus was less loud and bothersome.

For tDCS, research suggests it is generally safe when used properly. This method involves applying a small electrical current to the head. The most common side effects are mild skin issues, such as tingling or itching on the scalp. Clinical trials using tDCS have reported no serious side effects.

Overall, both treatments have been well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Transcranial Direct Current Stimulation (tDCS) and listening therapy for tinnitus because it offers a non-invasive approach that could modulate brain activity directly. Unlike standard treatments like cognitive behavioral therapy or medication, which often focus on managing symptoms without targeting the brain's electrical activity, tDCS delivers a gentle electrical current to the scalp, potentially altering neural pathways associated with tinnitus. This mechanism, alongside listening therapy, aims to retrain the brain's response to sound, providing a unique dual-action approach that could improve outcomes for tinnitus sufferers.

What evidence suggests that this trial's treatments could be effective for tinnitus?

Research has shown that active listening therapy, one of the treatments in this trial, can greatly reduce tinnitus symptoms, such as ringing or buzzing in the ears. One study found that participants noticed a clear decrease in tinnitus loudness after using sound therapy. Another study found that longer daily use of sound therapy led to even greater improvements in how much tinnitus bothered them.

For transcranial direct current stimulation (tDCS), another treatment option in this trial, studies have also shown encouraging results. In some cases, about 73.7% of patients experienced a meaningful reduction in tinnitus symptoms after tDCS treatment. Both single and repeated sessions have demonstrated moderate to significant effects in easing tinnitus. Together, these treatments, tested in separate arms of this trial, offer hope for those dealing with tinnitus. ^{3 6 7 8 9}

Who Is on the Research Team?

Aneta Kielar, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with chronic tinnitus or hyperacusis lasting more than 8 months. It's not suitable for those with head trauma, brain surgery, psychiatric disorders, metal implants in the body (including cochlear implants), epilepsy history, other neurological conditions, specific ear diseases like Meniere's Disease or otosclerosis, and severe hearing loss.

Inclusion Criteria

I have had ringing in my ears or sensitivity to sound for over 8 months.

I have had ringing in my ears or sensitivity to sound for over 8 months.

Exclusion Criteria

I have a history of Meniere's Disease, pulsatile tinnitus, otosclerosis, or chronic headaches.

Your hearing loss is greater than 70 decibels.

My hearing loss changes or is caused by issues in the ear's ability to conduct sound.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Baseline hearing and tinnitus assessment, MRI scan, and EEG-ERP recording

1 week

1 visit (in-person)

Treatment Part 1

tDCS with active listening therapy sessions

2 weeks

5 visits per week (in-person)

Rest and Post-Treatment Assessment

Rest period with post-treatment assessment, MRI scan, and EEG-ERP session

2 weeks

1 visit (in-person)

Treatment Part 2

tDCS with active listening therapy sessions

2 weeks

5 visits per week (in-person)

Rest and Post-Treatment Assessment

Rest period with post-treatment assessment, MRI scan, and EEG-ERP session

2 weeks

1 visit (in-person)

Follow-up

2-month follow-up with tinnitus assessment, MRI scan, and EEG-ERP session

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Active Listening Therapy
• Sham tDCS
• Transcranial Direct Current Stimulation (tDCS)

Trial Overview

The study tests transcranial direct current stimulation (tDCS) combined with listening therapy to treat tinnitus and hyperacusis. Participants will either receive real tDCS treatment or a sham (fake) version to compare effectiveness.

How Is the Trial Designed?

Group I: active TDCS and listening therapy Active Control 1 Intervention

TDCS will be administered with NeurConn1 Channel DC-Stimulator Plus (neuroCare Group, München, Germany) according to established guidelines and procedures. The active tDCS will be delivered for 20 minutes at 2mA with a 15-s ramp-up and ramp-down period. Excitatory/anodal tDCS or sham will be administered alongside active listening therapy 5 times a week for 2 weeks.

Group II: sham TDCS and listening therapy Placebo Group 1 Intervention

The sham stimulation will also last for 20 min with 15 sec ramp-up and ramp-down, except the current will be turned down gradually to 0 milliamperes (mA) after 30 seconds. The sham procedure provides the same tingling and itching sensation felt during active tDCS. The sham parameters were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade out in the first 30 s of tDCS

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11077254/

Investigation of the effectiveness of sound enrichment in the ...

Sound enrichment treatment can be effective in tinnitus cases where RI is positive and the tinnitus pitch is matched with a hearing loss between 45 and 55 dB ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10885923/

The Effectiveness of Microcurrent Stimulation Combined with ...

In another study, 5 of 15 participants with chronic tinnitus who received sound therapy reported significant relief from tinnitus [8]. Sound ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0378595525001534

Chronic tinnitus is quietened by sound therapy using a ...

Results showed a significant, persisting, reduction in self-rated tinnitus loudness after the active (p = 0.012), but not sham (p = 0.916) intervention.

4.

pubs.asha.org

pubs.asha.org/doi/10.1044/2022_JSLHR-21-00651

The Impact of Daily Hours of Sound Therapy on Tinnitus ...

Longer daily sound therapy hours were associated to a greater effect of sound therapy in the tinnitus loudness level and the total K-TPFQ scores.

5.

frontiersin.org

frontiersin.org/journals/audiology-and-otology/articles/10.3389/fauot.2024.1322596/full

Impact of a combination sound therapy on tinnitus distress

A combination sound therapy consisting of therapy sounds, amplification as needed, and counseling was associated with a reduction in tinnitus-related distress.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10727622/

The effect of music therapy on tinnitus: A systematic review

This meta-analysis of accumulated clinical trial data suggests that music therapy can relieve tinnitus symptoms and loudness.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04934371

Study Details | NCT04934371 | Treatment of Tinnitus With ...

The goal of this study is to use non-invasive transcranial direct current stimulation (tDCS) combined with active listening therapy to treat tinnitus and ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9073599/

Chronic Tinnitus and the Positive Effects of Sound ...

Sound therapy does not cure the condition, but may significantly lower its severity, reducing the level of distress or impact that tinnitus has on the ...

9.

tinnitusjournal.com

tinnitusjournal.com/articles/a-review-of-a-steady-state-coherent-biomodulator-for-tinnitus-relief--summary-of-efficiency-and-safety-data-from-the-clinical-stud-10407.html

A Review of a Steady State Coherent Bio-modulator ...

A Review of a Steady State Coherent Bio-modulator for Tinnitus Relief & Summary of Efficiency and Safety Data from the Clinical Study Program ...