Repetitive Transcranial Magnetic Stimulation for Chronic Subjective Tinnitus
- Conditions
- Tinnitus, Subjective
- Interventions
- Procedure: Repetitive Transcranial Magnetic StimulationProcedure: Sham stimulation
- Registration Number
- NCT03425045
- Lead Sponsor
- University Hospital Ostrava
- 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%.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- subjective chronic non-pulsatile tinnitus lasting more than 6 months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ginkgo Biloba Extract Ginkgo Biloba Extract Patients in this study arm will receive medication therapy as described above, without any rTMS or sham procedure. Repetitive Transcranial Magnetic Stimulation Repetitive Transcranial Magnetic Stimulation Patients in this study arm will undergo the rTMS stimulation as described above. Sham stimulation Sham stimulation Patients in this study arm will undergo the sham stimulation as described above.
- Primary Outcome Measures
Name Time Method Tinnitus Reaction Questionnaire (TRQ) 36 months This questionnaire will be used to find out what sort of effects tinnitus has had on the lifestyle and general well-being of the patients. 10% improvement will be considered clinically relevant.
Tinnitus Handicap Questionnaire (THQ) 36 months This questionnaire has 27 questions and will be used to assess the degree of handicap that the tinnitus presents for the affected patients. 10% improvement will be considered clinically relevant.
Tinnitus Handicap Inventory (THI) 36 months The purpose of this questionnaire is to identify difficulties the affected patients may be experiencing because of tinnitus. 10% improvement of the score will be considered clinically relevant.
- Secondary Outcome Measures
Name Time Method Improvement of depression - Beck Depression Inventory 36 months Improvement of depressive symptoms in patients will be assessed using the Beck Depression Inventory (BDI) test.
Improvement of hearing loss - Fowler scoring 36 months Improvement of the hearing loss in patients will be assessed using the pure-tone audiometry with Fowler scoring of hearing loss (%).
Trial Locations
- Locations (1)
University Hospital Ostrava
🇨🇿Ostrava, Moravian-Silesian Region, Czechia