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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Neuromodulation and Listening Therapy for Tinnitus?

Some studies suggest that transcranial direct current stimulation (tDCS), a part of the treatment, can be effective for managing tinnitus by altering brain activity in specific areas. However, results are mixed, and more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans as it involves a low-intensity electrical current applied to the scalp. Studies have shown it can be used for conditions like tinnitus, depression, and anxiety without significant adverse effects. ^{1 2 3 6 7}

How is the treatment of Active Listening Therapy and tDCS for tinnitus different from other treatments?

This treatment is unique because it combines Active Listening Therapy with transcranial direct current stimulation (tDCS), a noninvasive method that can adjust brain activity by applying a small electrical current to specific areas. Unlike traditional treatments, tDCS can target specific brain regions involved in tinnitus, potentially offering a more tailored approach. ^{1 2 3 4 8}

What is the purpose of this trial?

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

Research Team

Aneta Kielar, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

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

Survey of tinnitus patients' acceptance of high-definition transcranial direct current stimulation as a management option. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Cathodal neuromodulation of dominant temporoparietal cortex with transcranial direct current stimulation for tinnitus: A case series. [2019]

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

Effects of Electrical Stimulation in Tinnitus Patients: Conventional Versus High-Definition tDCS. [2019]

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

Modulation of Perception or Emotion? A Scoping Review of Tinnitus Neuromodulation Using Transcranial Direct Current Stimulation. [2015]

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

Transcranial direct current stimulation intensity and duration effects on tinnitus suppression. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Determining the effects of transcranial direct current stimulation on tinnitus and tinnitus-related outcomes: protocol for a systematic review. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Determining the Effects of Transcranial Direct Current Stimulation on Tinnitus, Depression, and Anxiety: A Systematic Review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for the treatment of tinnitus: a review of clinical trials and mechanisms of action. [2019]