Ignite Creation Date:
2024-05-06 @ 1:10 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03953521
Status:
TERMINATED
Last Update Posted:
2020-06-01
First Post:
2019-05-14
Brief Title:
Neuronavigated TBS in Depression
Sponsor:
University of Regensburg
Organization:
University of Regensburg
Study Overview
Official Title:
Neuronavigated Theta Burst Stimulation in Depression
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis indicated no statistical difference between treatment arms
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
neuronaviTBS
Brief Summary:
In this randomized controlled trial we will treat 80 patients with depression with intermittent theta burst stimulation in two parallel arms Both arms are active interventions differing with respect to positioning of the treatment coil - one arm with neuronavigation and one arm with targeting according to EEG Position representing the left dorsolateral prefrontal cortex Randomisation will be balanced for in- and out-patients and for the treatment arms
Detailed Description:
Intermittent Theta burst Stimulation iTBS is a specific type of repetitive transcranial magnetic Stimulation rTMS rTMS of the left prefrontal cortex was shown to be effective in the treatment of Depression Recent studies showed that iTBS probably is as effective as rTMS
One possibility to increase to efficacy of rTMSiTBS is to use neuronavigation With neuronavigation the coil Position can be targeted with an accuracy in the range of millimeters Furthermore the Stimulation Position can be ensured during one single session and over the course of the daily Treatments
The aim of the present study is to investigate the benefit of neuronavigation in the Treatment of Depression with iTBS by using two arms one with targeting the Stimulation site with neuronavigation and one by using the EEG Position F3 as target by using head caps for marking the position
One possibility to increase to efficacy of rTMSiTBS is to use neuronavigation With neuronavigation the coil Position can be targeted with an accuracy in the range of millimeters Furthermore the Stimulation Position can be ensured during one single session and over the course of the daily Treatments
The aim of the present study is to investigate the benefit of neuronavigation in the Treatment of Depression with iTBS by using two arms one with targeting the Stimulation site with neuronavigation and one by using the EEG Position F3 as target by using head caps for marking the position
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