Ignite Creation Date:
2024-05-06 @ 2:28 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02053961
Status:
WITHDRAWN
Last Update Posted:
2018-01-25
First Post:
2014-01-28
Brief Title:
Deep TMS of the Left Auditory Cortex Using the HMCIPCC Coil in the Treatment of Patients With Tinnitus
Sponsor:
Brainsway
Organization:
Brainsway
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WITHDRAWN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:
None
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?:
None