Repetitive Transcranial Magnetic Stimulation for Chronic Subjective Tinnitus

University Hospital Ostrava

Status: Completed

Conditions: Tinnitus, Subjective

Treatments: Drug: Ginkgo Biloba Extract; Procedure: Sham stimulation; Procedure: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03425045

FNO-ENT-tinnitus

MH CZ-DRO (FNOs/2015) (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 40 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 3 patient groups

Repetitive Transcranial Magnetic Stimulation

Experimental group

Description:

Patients in this study arm will undergo the rTMS stimulation as described above.

Treatment:

Procedure: Repetitive Transcranial Magnetic Stimulation

Sham stimulation

Sham Comparator group

Description:

Patients in this study arm will undergo the sham stimulation as described above.

Treatment:

Procedure: Sham stimulation

Ginkgo Biloba Extract

Active Comparator group

Description:

Patients in this study arm will receive medication therapy as described above, without any rTMS or sham procedure.

Treatment:

Drug: Ginkgo Biloba Extract