Ignite Creation Date:
2024-05-06 @ 1:10 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03957122
Status:
TERMINATED
Last Update Posted:
2019-12-19
First Post:
2019-05-16
Brief Title:
Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation
Sponsor:
University of Regensburg
Organization:
University of Regensburg
Study Overview
Official Title:
Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The number of responders in the test sessions was too low
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
indiTMS
Brief Summary:
In the first visit a magnetic resonance imaging measurement will be done for the use of a neuronavigation System with the aim to control for stable coil position over the course of the trial EEG positions CP5CP6 will be used for positioning the coil Two test sessions will examine the temporary reductions in tinnitus loudness after 1Hz 10Hz 20Hz and 01Hz rTMS as control condition over left and right temporo-parietal junction accompanied by electroencephalography For the two-week treatment three arms will be evaluated standard treatment 1Hz left-sided in the groups with and without temporary reductions in test sessions and the best protocol as elicited in test sessions
Detailed Description:
Efficacy of repetitive transcranial magnetic stimulation rTMS in chronic tinnitus is moderate So far single sessions and daily treatment of rTMS were rarely combined Thus it is not clear if temporary reductions in tinnitus loudness as elicited by short single rTMS sessions can be transferred to daily rTMS treatment Thus the aim of the study is to investigate the efficacy and reliability of single sessions of rTMS in chronic tinnitus with respect to temporary reductions in tinnitus loudness accompanied with resting state electroencephalography measurements to investigate the neurophysiological correlates of tinnitus reductions Two test sessions within one week will be done on the left and right temporoparietal junction using 1Hz 10Hz 20Hz and 01Hz as active control condition In the next step patients are divided into three arms with the aim to investigate the efficacy of individualized rTMS The three arms are 1 patients with temporary tinnitus reductions in test sessions treatment with the best most reliable controlled and most tolerable protocol 2 patients with temporary tinnitus reductions in test sessions treatment with 1Hz left-sided rTMS 3 patients with no temporary tinnitus reductions in test sessions treatment with 1Hz left-sided rTMS Treatment will be done for 10 days Monday - Friday using 2000 pulses with 110 resting motor threshold Coil position will be tracked with neuronavigation to ensure stable coil Position over the course of the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None