Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT02053961
Brief Summary:
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
Detailed Description:
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:
1. The subject will be required to use earplugs to minimize risk of hearing impairment.
2. Motor threshold stimulation intensity will be determined prior to each TMS session. .
3. Subjects will receive either active TMS or sham treatment, depending on the experimental group to which they were assign. During the first 2 weeks, five treatment sessions will be administer each week. During the following 4 weeks, one treatment will be administer weekly. Overall, each subject will receive 16 TMS session in 6 treatment weeks.
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).
Study:
NCT02053961
Study Brief:
Protocol Section:
NCT02053961