rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network (Multisite rTMS)

University of Regensburg (UR)

Status: Completed

Conditions: Chronic Tinnitus

Treatments: Device: rTMS intervention 1; Device: rTMS intervention 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01663324

Uni-Reg-multisite-rTMS-Tin-01

Details and patient eligibility

About

Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.

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. Treatment remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. Additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. Targeting several core regions of this network by rTMS might constitute a promising strategy to enhance treatment effects. A new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of subjective chronic tinnitus
• THI > 38
• Duration of tinnitus more than 6 months

Exclusion criteria

• Objective tinnitus
• 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
• Prior treatment with TMS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

single site rTMS

Experimental group

Description:

Low frequency temporoparietal transcranial magnetic stimulation Intervention: Device: rTMS intervention 1

Treatment:

Device: rTMS intervention 1

multisite rTMS

Experimental group

Description:

Combined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation Intervention: Device: rTMS Intervention 2

Treatment:

Device: rTMS intervention 2