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The study is a double-blind study designed to evaluate the efficacy of deep transcranial magnetic stimulation (deep TMS) of the left auditory cortex using the HMCIPCC coil, in the treatment of patients with tinnitus
Stages of the study:
A. Patient recruitment stage: hearing tests battery including: otoscopy, tympanometry, pure-tone audiometry - 0 to 20 dB HL; 21 to 60 dB HL and more than 60 dB HL, tinnitus matching, TQ and VAS.
B. Patients will be assign to one of two study groups, Deep TMS over the left auditory cortex and Sham. .
C. TMS Acute treatment phase:
TMS treatment will be administer for two weeks: 5 days a week for half an hour. Before each TMS treatment session, patients will undergo training exercises designed to stimulate the neural network associated with attention processes Monitoring for evaluation of treatment efficacy and side effects will be perform on a daily basis. . The overall time of each session is estimate to be 1 hour.
D. TMS Maintenance phase:
Four additional TMS treatment sessions will be administered once weekly for another 4 weeks.
Long-term durability of treatment effect will be assessed up to 90 days after the last TMS session.
E. TMS treatment program:
F. Safety:
Throughout the trial subjects will be constantly monitored by a physician. Any adverse effect or subjective discomfort experienced will be documented and addressed.
Magnetic stimulation treatment will be administered by an operator trained and certified by Brainsway.
Subjects who wish to withdraw from the study will be free to do so at any point.
Drugs belonging to benzodiazepine class will be permitted if necessary at daily doses up to the equivalent of 2 mg Lorazepam (Lorivan).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1Hz dTMS Real | Active Comparator | This group will receive dTMS real treatment of 1Hz |
|
| 1HZ dTMS SHAM | Sham Comparator | This group will receive 1HZ dTMS SHAM treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Transcranial Magnetic Stimulation | Device | 1Hz dTMS real treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| TQ - Tinnitus questionnaire | 90 days after the last treatment session |
| Measure | Description | Time Frame |
|---|---|---|
| VAS (100 - worst possible tinnitus related discomfort; 0 - wellness) | baseline, week 1: day 1-5, and week 2: day 1-5 |
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Inclusion Criteria:
Exclusion Criteria:
A DSM-IV Axis-I psychiatric disorder.
Use of medication that may be a risk factor for seizures, such as:
antipsychotic medication; high dosage of antidepressant medication; drugs belonging to benzodiazepine class will be permitted if necessary at daily doses up to the equivalent of 2 mg Lorazepam (Lorivan)' any other drug that is considered a risk factor for seizures by the Principal Investigator.
History of intolerance to TMS.
Diagnosis of a severe personality disorder according to the DSM-IV.
Current suicidal ideation.
Uncontrolled hypertension.
History of epilepsy, seizure, or heat convulsion.
History of epilepsy or seizure in first degree relatives.
History of head injury or stroke.
History of any metallic particles in the head (except dental fillings).
History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemakers, cochlear implants, use of neurostimulators, or any medical pumps.
History of drug or alcohol abuse.
Inability to communicate adequately with examiner.
Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
Inability to sign a consent form.
Pregnancy or inadequate birth control.
Severe hearing impairment.
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| Name | Affiliation | Role |
|---|---|---|
| Yair Lampel, Prof. | Neurology Department, Wolfson Hospital, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfson Hospital | Holon | Israel |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Deep Transcranial Magnetic Stimulation | Device | 1Hz dTMS SHAM treatment |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |