Clinical trial NCT03425045: Repetitive Transcranial Magnetic Stimulation for Chronic Subjective Tinnitus
Official title: Repetitive Transcranial Magnetic Stimulation for Chronic Subjective Non-Pulsatile Primary Tinnitus Compared to Placebo and Medicament Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Keywords: chronic tinnitus
repetitive transcranial magnetic stimulation
hypacusion
depression
treatment
placebo
medication therapy
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as interventional, blinded, randomized, controlled trial with three parallel arms
Primary purpose: TREATMENT

Brief summary: Therapy of subjective chronic primary tinnitus could be challenging. Repetitive transcranial magnetic stimulation (rTMS) is currently being tested for suppressing the symptoms. However, effect of stimulation remains controversial. The aim was to uncover real effect of rTMS stimulation for tinnitus treatment. There will be three groups, stimulation group, sham stimulation group and controlled group with medicament treatment. The investigators assume that combination of rTMS stimulation of dorsolateral prefrontal cortex and primary auditory cortex at both sides will be more efficient. The investigators considered a 10% improvement in the tinnitus questionnaire score and in the tinnitus masking to be clinically relevant.

Detailed description: Adult patients suffering from chronic subjective non-pulsatile primary unilateral or bilateral tinnitus for at least 6 months will be included in the study. Patients will be randomly assigned using a random number generation randomization method into rTMS stimulation group (group 1), sham stimulation group (group 2) and group with medicament therapy only (group 3). Dorsolateral prefrontal cortex (frequency 25 Hz; 300 pulses; 80% resting motor threshold=RMT) and primary auditory cortex on both sides (1 Hz; 1000 pulses; 110% RMT) will be stimulated in patients in rTMS stimulation group for 5 consecutive days. Both the patients and outcome assessor were blinded to the intervention group in which the patients (rTMS and shame stimulation group) belonged to. Medicament therapy in group 3 will consist of ginkgo biloba extract EGb 761 once a day for 6 months. There will be no medicament therapy for tinnitus in group 1 and 2. Tinnitus reaction questionnaire (TRQ), tinnitus handicap questionnaire (THQ), tinnitus handicap inventory (THI), Beck Depression Inventory (BDI), pure-tone audiometry with Fowler scoring of hearing loss and tinnitus analysis will be used for evaluation of tinnitus in all patients. Data will be recorded on the day patient is included in the study, during follow-up after 1 month and 6 months. Descriptive statistics, such as the arithmetic mean, standard deviation, and absolute and relative frequency tables, will be used for data processing. The Pearson's chi-squared test, Fisher's exact test, Kruskal-Wallis test and analysis of variance will be used for comparison. The statistical tests will be assessed using a significance level of 5%.

Eligibility criteria: Inclusion Criteria:

- subjective chronic non-pulsatile tinnitus lasting more than 6 months

Exclusion Criteria:

* head injury or brain surgery
* epilepsy
* organic brain lesion
* Meniere's disease or fluctuating hearing loss
* cochlear or bone-anchored hearing device implantation
* history of suicide
* pregnancy
* therapy with anticonvulsants
* antipsychotic medication
* heart pacemaker implantation
* rTMS performed in the past
* not signing of the informed consent

Primary outcomes:
measure: Tinnitus Reaction Questionnaire (TRQ)
timeFrame: 36 months
measure: Tinnitus Handicap Questionnaire (THQ)
timeFrame: 36 months
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 36 months
Secondary outcomes:
measure: Improvement of depression - Beck Depression Inventory
timeFrame: 36 months
measure: Improvement of hearing loss - Fowler scoring
timeFrame: 36 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Michal Bar, Ass.Prof.,MD,PhD
role: PRINCIPAL_INVESTIGATOR
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