drugset / Trial / NCT04653337

Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression

NCT04653337

Phase 2 Unknown 56 enrolled Xijing Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

There is relatively insufficient evidence on whether rTMS can improve suicidal ideation in depressive patients. And existing studies have been inconsistent in the treatment of depressive suicidal thoughts. The possible reason is inaccurate stimuli localization. Improving the accuracy of rTMS stimulus positioning may further improve the intervention effect of suicidal ideation. This study will introduce an automated TMS system with robot control and optical sensor combined with neuronavigation softwarea. By using the robot based on neuronavigation system, the rTMS coil can be accurately positioned over any preselected brain region. An infrared optical measurement device is also used in order to detect and compensate for head movements of the patient. The purpose of this randomized double-blind and sham-controlled study is to test the efficacy and safety of robot-assisted rTMS based on neuronavigation in the treatment of depressive suicidal ideation.

Timeline

Start
2020-09-28
Primary completion
2023-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Background Duloxetine Small molecule
Background Venlafaxine Small molecule

Indications