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Neuromodulation and Listening Therapy for Tinnitus (TDCS Trial)

N/A

Waitlist Available

Led By Aneta Kielar, PhD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (18-80 years old)

adults (18-80 years old)

Must not have

Conductive hearing loss, or fluctuating hearing thresholds

Personal or family history of epilepsy, other seizure disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Summary

This trial is testing a new treatment for tinnitus that uses electric currents to stimulate the brain. The treatment is combined with therapy to help patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of tDCS may include mild discomfort at the electrode site on the scalp, itching sensation during stimulation, headache after treatment sessions, fatigue or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I am between 18 and 80 years old.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I or someone in my family has epilepsy or another seizure disorder.

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I have been diagnosed with a neurological disorder such as stroke, Parkinson's, dementia, or a brain tumor.

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I have not had recent head trauma, brain surgery, or psychiatric disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in the Sound Tolerance Questionnaire ratings

Mean change in tinnitus and hyperacusis ratings on the Visual Analog Scale

Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS)

+2 more

Secondary study objectives

change in electrophysiological measures

change in functional connectivity measured with fMRI

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: active TDCS and listening therapyActive Control1 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 therapyPlacebo Group1 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

0 / 8Eligibility criteria met