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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

TDCS Trial 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.Check my eligibility

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.See study design

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.

TDCS Trial 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.

TDCS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

change in electrophysiological measures

change in functional connectivity measured with fMRI

TDCS 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,241 Total Patients Enrolled

2 Trials studying Hearing Loss

148 Patients Enrolled for Hearing Loss

Aneta Kielar, PhDPrincipal InvestigatorUniversity of Arizona

2 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Active Listening Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04934371 — N/A

Hearing Loss Research Study Groups: active TDCS and listening therapy, sham TDCS and listening therapy

Hearing Loss Clinical Trial 2023: Active Listening Therapy Highlights & Side Effects. Trial Name: NCT04934371 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation still accept new participants?

"The clinical trial registry states that this particular study is not presently taking on participants. It was first posted in September 2022 and its most recent update was at the end of June. However, there are 53 other trials currently enrolling patients for additional research opportunities."

Answered by AI

Does this research program allow individuals over 35 to participate?

"Prospective participants of this study must be between 18 and 80 years old."

Answered by AI

What are the criteria for enrolment in this trial?

"The requirements to join this clinical trial are that participants have dysacusis and be between 18 and 80 years old. To facilitate the research, 30 patients must be recruited in total."

Answered by AI

Who else is applying?

What state do they live in?

North Carolina

Other

Texas

Arizona

How old are they?

65+

18 - 65

What site did they apply to?

University of Arizona

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

My healthcare provider has no treatment solutions for this ongoing issue. I AM A RETIRED ARMY VET WITH TINNITUS. LIVING WITH THIS NCONSTANT NOISE IS A BURDEN. I SEEK RELIEF.

PatientReceived no prior treatments

I have had tinnitus for many years and would like to help find a solution or at least a way to reduce it.

PatientReceived 1 prior treatment

I've had chronic tinnitus for several years, with increasing intensity. It's had a really deleterious effect on my personal, social and work life.

PatientReceived 1 prior treatment

I have suffered from Tinnitus in my left ear for about two years now and I'm motivated to do something to try to reduce the noise and/or eliminate it.

PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long is the duration of the trial? I'm commuting from Phoenix. The study summary was unclear on the timing of each of the therapy sessions. Ho many days each week in Tucson?

PatientReceived no prior treatments