Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Tinnitus (tRNS2-tin)

University of Regensburg (UR)

Status: Enrolling

Conditions: Chronic Tinnitus

Treatments: Device: lf-tRNS

Study type: Interventional

Funder types: Other

Identifiers

NCT02615600

Uni-Reg-tRNS02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of bothersome, subjective chronic tinnitus
• diagnosis: duration of tinnitus more than 6 months

Exclusion criteria

• objective tinnitus
• irregular head shap below the electrodes
• eczema on the head
• treatable cause of the tinnitus
• involvement in other treatments for tinnitus at the same time
• clinically relevant psychiatric comorbidity
• clinically relevant unstable internal or neurological comorbidity
• history of or evidence of significant brain malformation or neoplasm, head injury
• cerebral vascular events
• neurodegenerative disorder affecting the brain or prior brain surgery
• metal objects in and around body that can not be removed
• pregnancy
• alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

lf-tRNS

Experimental group

Description:

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

Treatment:

Device: lf-tRNS