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

NCT04653337 · Xijing Hospital · Updated 5 April 2023

What is being tested
Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)
For
Suicidal Ideation; Depression
Kind of study
Tests a treatment or device on volunteers. Phase 2.
Who can join
Ages 18 years to 60 years. About 56 people. The full rules are on the registry page.
Where
China
When
Starts or started 28 Sept 2020, ends 31 Dec 2023. Registered 4 Dec 2020.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT04653337

Sites

  • XijingHXi'an, Shaan'xi, China