Tinnitus, Subjective Clinical Trial
— TDCSOfficial title:
Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy: A Double-blind, Sham-controlled, Crossover Study
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 15, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - chronic tinnitus and or hyperacusis (> 8 months) - adults (18-80 years old) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona |
United States,
Arul-Anandam AP, Loo C, Sachdev P. Transcranial direct current stimulation - what is the evidence for its efficacy and safety? F1000 Med Rep. 2009 Jul 27;1:58. doi: 10.3410/M1-58. — View Citation
Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. doi: 10.1177/014107680309601203. No abstract available. — View Citation
Cardon E, Joossen I, Vermeersch H, Jacquemin L, Mertens G, Vanderveken OM, Topsakal V, Van de Heyning P, Van Rompaey V, Gilles A. Systematic review and meta-analysis of late auditory evoked potentials as a candidate biomarker in the assessment of tinnitus. PLoS One. 2020 Dec 17;15(12):e0243785. doi: 10.1371/journal.pone.0243785. eCollection 2020. — View Citation
Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19. — View Citation
Henry JA, Griest S, Zaugg TL, Thielman E, Kaelin C, Galvez G, Carlson KF. Tinnitus and hearing survey: a screening tool to differentiate bothersome tinnitus from hearing difficulties. Am J Audiol. 2015 Mar;24(1):66-77. doi: 10.1044/2014_AJA-14-0042. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS) | 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) | through study completion, an average of 1 year | |
Primary | Mean change in the Sound Tolerance Questionnaire ratings | change in the hyper-sensitivity to sound on a scale 0-10 (Max =10, higher score indicates greater sensitivity) | through study completion, an average of 1 year | |
Primary | mean change on the Tinnitus Functional Index (TFI) scores | change in the tinnitus perception on a scale 0-10 (Max = 10: higher score indicates greater impairment) | through study completion, an average of 1 year | |
Primary | mean change on the Tinnitus Primary Function Questionnaire (TPFQ) | change in the tinnitus perception (score: 0-10; higher score indicates more severe tinnitus) | through study completion, an average of 1 year | |
Primary | Mean change in tinnitus and hyperacusis ratings on the Visual Analog Scale | participants' rating on the Visual Analog Scale pre vs. post treatment (0-10), higher scores indicate greater impairment | through study completion, an average of 1 year | |
Secondary | change in electrophysiological measures | change in mean latency and amplitude of the ERP responses (lower amplitude and increased latency indicate worse performance) | through study completion, an average of 1 year | |
Secondary | change in functional connectivity measured with fMRI | changes in functional connectivity from pre to post intervention (increase or decrease possible) | through study completion, an average of 1 year |
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