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Stimulation of the left and right auditory cortex with daily low-frequency transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.
Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. These changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. First data suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. Low-frequency (lf; <100Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily lf-tRNS (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm pilot trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lf-tRNS | Experimental | Low-frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): <100Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lf-tRNS | Device | Low-frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): <100Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 |
| Measure | Description | Time Frame |
|---|---|---|
| number of treatment responders | response: tinnitus questionnaire total score reduction of at least 5 points, contrast baseline versus end of treatment (week 12) | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| change in tinnitus questionnaire | change in tinnitus questionnaire | week 2, week 4, week 12 |
| change in tinnitus handicap inventory | change in tinnitus handicap inventory |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Langguth | University of Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Regensburg - Deptartment of Psychiatry | Regensburg | 93053 | Germany |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| week 2, week 4, week 12 |
| change in tinnitus numeric rating scales | change in tinnitus numeric rating scales | week 2, week 4, week 12 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |