Treatment of Tinnitus and Hyperacusis with Neuromodulation

This study is looking for adults aged 18-80 who have had chronic tinnitus (ringing or buzzing in the ears) and/or hyperacusis (unusual sensitivity to sounds) for at least 8 months. The goal is to see if combining transcranial direct current stimulation (tDCS), which sends weak electrical currents to the brain, with listening therapy can help reduce these symptoms. Researchers will measure changes in your tinnitus severity, how much it bothers you, and your sound tolerance over about one year. You cannot participate if you have metal implants, bullet wounds, head/neck tattoos, metal in your eyes, or other diagnosed neurological disorders. The current status of recruitment is unclear.

Study design
This interventional study plans to enroll 30 participants. It uses a sham control, meaning some participants will receive an inactive version of the tDCS device.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your tinnitus severity, annoyance, sound tolerance, and functional index scores will be measured through study completion, which is an average of one year.

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NCT04934371

Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy

UNKNOWN
NAAges 18–80InterventionalTreatment
University of Arizona
~30 participants
Updated 2024-05-08 on ClinicalTrials.gov
What's tested:Transcranial Direct Current Stimulation (tDCS)Sham TDCS

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS)
Measured over through study completion, an average of 1 year
+4 more outcomes measured
Tinnitus, Subjective
Hyperacusis
Hearing Disorders
1 sites across 1 states
Arizona1
  • Aneta Kielar, PhD · PRINCIPAL_INVESTIGATOR · University of Arizona

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Eligibility criteria

Inclusion

chronic tinnitus and or hyperacusis (\> 8 months)
adults (18-80 years old)

Exclusion

implanted metal or devices including cochlear implants,
bullet wounds, head/neck tattoo,
metal in the eyes,
other diagnosed neurological disorders (e.g., stroke, Parkinson's, dementia, brain tumors),
head trauma or brain surgery, psychiatric disorders,
personal or family history of epilepsy, other seizure disorders
Individuals with a history of Meniere's Disease, pulsatile tinnitus, otosclerosis, and
chronic headaches.
conductive hearing loss, or
fluctuating hearing thresholds
pure tone averages \>70dB HL
  • Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS)through study completion, an average of 1 year

    change in participants' perception of tinnitus severity on a 0-4 numeric scale compared pre vs. post intervention (Max = 4; higher score indicates more severe tinnitus)

  • Mean change in the Sound Tolerance Questionnaire ratingsthrough study completion, an average of 1 year

    change in the hyper-sensitivity to sound on a scale 0-10 (Max =10, higher score indicates greater sensitivity)

  • mean change on the Tinnitus Functional Index (TFI) scoresthrough study completion, an average of 1 year

    change in the tinnitus perception on a scale 0-10 (Max = 10: higher score indicates greater impairment)

  • mean change on the Tinnitus Primary Function Questionnaire (TPFQ)through study completion, an average of 1 year

    change in the tinnitus perception (score: 0-10; higher score indicates more severe tinnitus)

  • Mean change in tinnitus and hyperacusis ratings on the Visual Analog Scalethrough study completion, an average of 1 year

    participants' rating on the Visual Analog Scale pre vs. post treatment (0-10), higher scores indicate greater impairment