Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus

Study Overview
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Brief Summary
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Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to modulate auditory cortex activity and plasticity contributing to the perception and distress of chronic tinnitus.

Detailed Description
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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. One significant modulator of tinnitus is stress. 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. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporal and temporoparietal areas. Continuous theta burst stimulation (cTBS) is a new protocol of rTMS with a possible superior effect in contrast to low-frequency rTMS. Also anatomical neuronavigation might increase the efficacy of rTMS due to exact targeting of the primary auditory cortex. Thus, the aim of this study is the evaluation of the clinical efficacy of neuronavigated left-sided cTBS in chronic tinnitus in a randomised sham-controlled two-arm design.

Official Title
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Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus

Conditions
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Chronic Tinnitus

Intervention / Treatment
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* Device: Left temporal verum cTBS
* Device: Left temporal placebo cTBS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of bothersome, subjective chronic tinnitus 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 acute or chronic inflammation of the middle ear, Meniere diseases, sudden idiopathic hearing loss, fluctuating hearing history of seizures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left temporal verum cTBS<br>Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session) Intervention: Left temporal verum cTBS | Device: Left temporal verum cTBS<br>* Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session) Arms: Left temporal verum cTBS<br>* Other names: MC-B70, MagPro,MagOption, Medtronic, Germany;|
| Experimental: Left temporal placebo cTBS<br>Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings Intervention: Left temporal placebo cTBS | Device: Left temporal placebo cTBS<br>* Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings Arms: Left temporal placebo cTBS<br>* Other names: MC-B70, MagPro,MagOption, Medtronic, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tinnitus questionnaire total score (contrast baseline (-day 3) versus end of treatment (day 10)) |  | -day 3; day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tinnitus questionaire total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8)) |  | -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8 | 
| Change of tinnitus handicap inventory total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8)) |  | -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8 | 
| Change of tinnitus numeric rating scales (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8)) |  | -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8 | 
| Change of depressive symptoms as measured by the Beck Depression Inventory II (BDI) (baseline visit -week 2 vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8)) |  | -week 2; day 6; day 10; week 1; week 3; week 8 |