Repetitive Transcranial Magnetic Stimulation for Chronic Subjective Non-Pulsatile Primary Tinnitus Compared to Placebo and Medicament Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Tinnitus Reaction Questionnaire (TRQ)
Study Overview
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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •subjective chronic non-pulsatile tinnitus lasting more than 6 months
Exclusion Criteria
- •head injury or brain surgery
- •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
Arms & Interventions
Repetitive Transcranial Magnetic Stimulation
Patients in this study arm will undergo the rTMS stimulation as described above.
Intervention: Repetitive Transcranial Magnetic Stimulation (Procedure)
Sham stimulation
Patients in this study arm will undergo the sham stimulation as described above.
Intervention: Sham stimulation (Procedure)
Ginkgo Biloba Extract
Patients in this study arm will receive medication therapy as described above, without any rTMS or sham procedure.
Intervention: Ginkgo Biloba Extract (Drug)
Outcomes
Primary Outcomes
Tinnitus Reaction Questionnaire (TRQ)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Improvement of depression - Beck Depression Inventory(36 months)
- Improvement of hearing loss - Fowler scoring(36 months)