Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-04 @ 4:27 PM
Study NCT ID:
NCT02053961
Status:
WITHDRAWN
Last Update Posted:
2018-01-25
First Post:
2014-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep TMS of the Left Auditory Cortex Using the HMCIPCC Coil, in the Treatment of Patients With Tinnitus.
Sponsor:
Brainsway
Organization:
Study Overview
Official Title:
The Efficacy of dTMS Among Patient Who Suffer From Tinnitus
Status:
WITHDRAWN
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: