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Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy

Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy: A Double-blind, Sham-controlled, Crossover Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04934371
Acronym
TDCS
Enrollment
30
Registered
2021-06-22
Start date
2025-01-15
Completion date
2025-12-15
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Disorders, Hyperacusis, Tinnitus, Subjective

Brief summary

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.

Detailed description

Tinnitus is characterized by the subjective perception of sound in the ears or in the brain without external stimulus. In about 30-50% of patients, tinnitus co-occurs with hyperacusis, which is abnormal sensitivity to sounds even at low levels. Chronic tinnitus and hyperacusis can be devastating since a significant proportion of sufferers develop sleep disturbances, psychiatric conditions, and a small fraction commit suicide. Tinnitus is often accompanied by difficulty concentrating and impairment on tasks that require sustained attention and executive control. Currently there is no satisfactory treatment for tinnitus and hyperacusis, contributing to patients' distress. Thus, there is an urgent need for interventions that would suppress the symptoms and possibly cure the disorder. Although, the pathophysiology of tinnitus and hyperacusis is not well understood, neurobiological research suggests that tinnitus and hyperacusis can be attributed to maladaptive neuroplasticity triggered by damage in the auditory system. Most symptoms of tinnitus have been attributed to the hyperactivity and reorganization in the auditory cortex (AC) and dorsolateral prefrontal brain regions (DLPFC). This suggests that electrical stimulation to the abnormally activated regions might modulate these overactive regions and reduce tinnitus and hyperacusis. TDCS is a noninvasive neurostimulation technique that uses weak electric currents (1-2 mA) applied to the scalp to modulate brain responsiveness by temporarily altering neuronal resting membrane potentials. It is proposed that this approach has a potential therapeutic value in treating tinnitus and hyperacusis. Our proposed project examines whether application of tDCS to AC and DLPFC combined with active listening therapy serves to promote adaptive neuroplasticity and reduce subjective perception of sound and emotional distress. The Aims are to: (1) Determine whether tDCS can lead to significant improvement in tinnitus and hyperacusis symptoms pre- versus post-stimulation and (2) Examine electrophysiological responses and functional connectivity in the fronto-temporal-parietal network of brain regions in response to tDCS vs. sham. The expected outcomes from this research will provide evidence to support the design and implementation of individualized tDCS protocols to potentiate treatment protocols that address the core deficits in tinnitus and hyperacusis. Our data will contribute to a more detailed understanding of the neurobiology of tinnitus and the mechanisms that contribute to the subjective, emotional and cognitive symptoms. The results of our study have a potential to develop effective treatment for the rehabilitation of tinnitus and contribute to the clinical practice. Summary of study sequence and procedures: Week 1: Baseline screening, hearing assessment, tinnitus assessment (2 hours), one magnetic resonance imaging (MRI) scan (45minutes), one electrophysiology recording (EEG-ERP)( 1 hour) Weeks 2-4: tDCS with active listening therapy Part 1 * 2 weeks of 1-hour sessions using non-invasive brain stimulation paired with active listening therapy Weeks 5 and 6: rest-period, post-treatment assessment, one MRI scan (45 min), one EEG-ERP session (1hour) Weeks 7 to 9: tDCS with active listening therapy Part 2 (1 hour each sessions) * 2 weeks of 1-hour sessions using non-invasive brain stimulation paired with active listening therapy Weeks 10 and 12: rest period and post-treatment assessment one MRI scan (45 min), one EEG-ERP session (1hour) Week 18: 2-month follow-up, tinnitus assessment, one MRI scan (45 min), one EEG-ERP session (1 hour)

Interventions

DEVICETranscranial Direct Current Stimulation (tDCS)

TDCS is a procedure that sends weak electrical currents between points on the scalp. Some of this current flows through the brain, and may induce temporary changes in brain activity lasting 30-60 minutes beyond the time of stimulation. TDCS is believed to be very low risk. TDCS has been applied in more than 4900 studies and hundreds of people to treat various neurological and psychiatric conditions, including depression, epilepsy, chronic pain and Parkinson's. In this study we will use tDCS to suppress symptom of tinnitus and hyperacusis.

DEVICESham TDCS

Sham control will be administered to the same area as active TDCS

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

All audiological evaluations and tinnitus questionnaires performed before and after treatment will be carried out by trained personnel blind to the treatment condition. The neuroConn DC stimulator has a study mode where input codes will be used (the researcher and the participants will be blinded to these codes) and the settings generated will be either a sham or actual stimulation

Intervention model description

Each patient will undergo tDCS and active listening therapy. This will be double-blinded randomized-sham controlled intervention during which excitatory/anodal tDCS or sham will be administered alongside active listening therapy 5 times a week for 2 weeks. After 2-month follow up participants will be crossed-over to the other treatment type. (Model AB- BA

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mean change on the Tinnitus Functional Index (TFI) scoresthrough study completion, an average of 1 yearchange 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 yearchange 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 yearparticipants' rating on the Visual Analog Scale pre vs. post treatment (0-10), higher scores indicate greater impairment
Mean change in the Sound Tolerance Questionnaire ratingsthrough study completion, an average of 1 yearchange in the hyper-sensitivity to sound on a scale 0-10 (Max =10, higher score indicates greater sensitivity)
Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS)through study completion, an average of 1 yearchange 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)

Secondary

MeasureTime frameDescription
change in functional connectivity measured with fMRIthrough study completion, an average of 1 yearchanges in functional connectivity from pre to post intervention (increase or decrease possible)
change in electrophysiological measuresthrough study completion, an average of 1 yearchange in mean latency and amplitude of the ERP responses (lower amplitude and increased latency indicate worse performance)

Countries

United States

Contacts

Primary ContactAneta Kielar, PhD
akielar@email.arizona.edu520-621-5105
Backup ContactBarbara Cone, PhD
conewess@email.arizona.edu520-626-3710

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026