Tinnitus, Subjective
Conditions
Keywords
chronic tinnitus, repetitive transcranial magnetic stimulation, hypacusion, depression, treatment, placebo, medication therapy
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%.
Interventions
PROCEDURERepetitive Transcranial Magnetic Stimulation
Patients randomised in Arm 1 will receive stimulation of the 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. No medication therapy will be provided for patients in this arm.
PROCEDURESham stimulation
Sham stimulation will be performed in patients randomised in Arm 2 of the study for 5 consecutive days. No medication therapy will be provided for patients in this arm.
Patients randomised in Arm 3 of the study will receive medication therapy with Ginkgo biloba extract EGb 761 once a day for 6 months.
Sponsors
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The study subjects and outcomes assessors will be masked, the investigator will know which treatment is being provided for which patient.
Intervention model description
The study is designed as interventional, blinded, randomized, controlled trial with three parallel arms
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (%). |
Countries
Czechia
Outcome results
None listed