Tinnitus, Subjective
Conditions
Keywords
tinnitus, neuromodulation, non-invasive brain stimulation, transcranial direct current stimulation, large cohort, high-definition tDCS
Brief summary
Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-TDCS). The objective of the current study is to investigate the effect of HD-tDCS on tinnitus in a large patient cohort.
Interventions
1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY)
Sponsors
Universiteit Antwerpen
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic, subjective, non-pulsatile tinnitus * met the criteria for HD-tDCS safety
Exclusion criteria
* a middle ear pathology * another tinnitus treatment ongoing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tinnitus Functional Index (TFI) | Baseline (before intervention), immediately post intervention, 7 weeks follow-up | Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue scale (VAS) for tinnitus loudness | Baseline (before intervention), immediately post intervention, 7 weeks follow-up | Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus |
| Change in Hospital Anxiety and Depression Scale (HADS) | Baseline (before intervention), immediately post intervention, 7 weeks follow-up | Self-report questionnaire concerning anxiety and depression symptoms, ranging from 0-21 for each subscale. A result greater than 8 suggests the presence of a depression and/or anxiety disorder. Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus |
| Change in Tinnitus Questionnaire (TQ) | Baseline (before intervention), immediately post intervention, 7 weeks follow-up | Tinnitus severity self-report questionnaire, ranging from 0-84 with a higher score representing a more distressing tinnitus |
| Change in Hyperacusis Questionnaire (HQ) | Baseline (before intervention), immediately post intervention, 7 weeks follow-up | Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity. |
Outcome results
None listed