Clinical trial NCT02199106: Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus
Official title: Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tinnitus
Lead sponsor: University of Regensburg
Sponsor class: OTHER
Collaborators: name: University of Wuerzburg
name: University Hospital Tuebingen
name: University Hospital Muenster
First posted: 2014-07-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in tinnitus questionnaire total score (contrast baseline (-day 3) versus end of treatment (day 10))
timeFrame: -day 3; day 10
Secondary outcomes:
measure: 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))
timeFrame: -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8
measure: 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))
timeFrame: -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8
measure: 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))
timeFrame: -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8
measure: 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))
timeFrame: -week 2; day 6; day 10; week 1; week 3; week 8
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University of Muenster
city: Regensburg
country: Germany
facility: University of Regensburg - Dept of Psychiatry
city: Tuebingen
country: Germany
facility: University of Tuebingen
city: Wuerzburg
country: Germany
facility: University of Wuerzburg
Study officials:
affiliation: University of Regensburg
name: Berthold Langguth
role: PRINCIPAL_INVESTIGATOR
References: