Clinical trial NCT02653547: Influence of Treatment Duration and Stimulation Frequency on rTMS in Chronic Tinnitus
Official title: Influence of Treatment Duration and Stimulation Frequency on Repetitive Transcranial Magnetic Stimulation in Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tinnitus
Keywords: tinnitus
transcranial random noise stimulation
rTMS
multisite stimulation
non-invasive brain stimulation
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients receive two weeks of treatment (prefrontal high-frequency and bilateral low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After two weeks of treatment they can decide if they want to quit the treatment or if they want to proceed with the treatment for another two weeks.

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. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory and non-auditory neural pathways. Low-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus based on the rationale to reduce increased activity of the auditory system. Furthermore, high-frequency stimulation of the left frontal cortex was added to this standard treatment based on rTMS studies in affective disorders and the association of tinnitus distress with depressivity. Thus, high-frequency stimulation of the left prefrontal cortex and low-frequency stimulation of bilateral temporoparietal cortex was introduced as new treatment scheme in chronic tinnitus (multisite standard).

Additionally, there is also evidence that high-frequency stimulation of the temporoparietal cortex is effective in chronic tinnitus. Furthermore, standard treatment in chronic tinnitus is two weeks (ten treatment days) which is shorter than the standard in rTMS in affective disorders. Thus, the aim of the present trial is to investigate the influence of high-frequency stimulation of the temporoparietal cortex and of increasing the number of treatment days.

Patients receive two weeks of treatment (prefrontal high-frequency and bilateral low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After two weeks of treatment they can decide if they want to quit the treatment or if they want to proceed with the treatment for another two weeks.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* duration of tinnitus more than 6 months
* bothersome chronic tinnitus

Exclusion Criteria:

* not stable internal, mental, and neurological diseases
* contraindication for rTMS (pacemaker, metal implants, pregnancy, epilepsy, status post severe craniocerebral injury )
* uninvolvement in other treatment studies for tinnitus at the same time

Primary outcomes:
measure: change in tinnitus questionnaire
timeFrame: week12
Secondary outcomes:
measure: change in tinnitus questionnaire
timeFrame: week2, week3, week4, week12
measure: change in tinnitus handicap inventory
timeFrame: week2, week3, week4, week12
measure: change in tinnitus numeric rating scales
timeFrame: week2, week3, week4, week12
measure: change in major depression inventory
timeFrame: week2, week3, week4, week12
measure: change in clinical global impression
timeFrame: week2, week3, week4, week12
measure: change in quality of life
timeFrame: week2, week3, week4, week12
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg- Dept of Psychiatry
Study officials:
affiliation: University of Regensburg, Department of Psychiatry
name: Berthold Langguth
role: PRINCIPAL_INVESTIGATOR
References: