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

NCT04653337 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-04-05

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)

Subjects will receive a 5-day trial of robot-assisted accelerated iTBS-1800 (10 sessions of iTBS1800 with 50 min interval per day over 5 consecutive days) combined with SNRIs（Venlafaxine or Duloxetine).

COMBINATION_PRODUCT

Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)

Subjects will receive a 5-day trial of robot-assisted accelerated iTBS-600 (6 sessions of iTBS600 with 30 min interval per day over 5 consecutive days) combined with SNRIs（Venlafaxine or Duloxetine）

COMBINATION_PRODUCT

Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)

Subjects will receive a 5-day trial of sham accelerated iTBS (6 sessions of iTBS600 with 30 min interval per day over 5 consecutive days) combined with SNRIs（Venlafaxine or Duloxetine）

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • HuaNing WANG, PhD · Xijing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04653337 on ClinicalTrials.gov