Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Robot-assisted rTMS and Antidepressants Patients with suicidal ideation and depression will receive antidepressants combined with robot-assisted rTMS. |
Combination Product: Robot-assisted rTMS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)
Subjects will receive a 15-day trial of robot-assisted rTMS combined with SNRIs（Venlafaxine or Duloxetine）
|
| Active Comparator: Conventional rTMS and Antidepressants Patients with suicidal ideation and depression will receive antidepressants combined with conventional rTMS. |
Combination Product: Conventional rTMS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)
Subjects will receive a 15-day trial of conventional rTMS combined with SNRIs（Venlafaxine or Duloxetine）
|
| Sham Comparator: Sham rTMS and Antidepressants Patients with suicidal ideation and depression will receive antidepressants combined with sham rTMS. |
Combination Product: Sham rTMS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)
Subjects will receive a 15-day trial of conventional rTMS combined with SNRIs（Venlafaxine or Duloxetine）
|
Outcome Measures
Primary Outcome Measures
- Beck Scale for Suicidal Ideation-Chinese Version（BSI-CV) [Baseline, after 7 days of treatment, after 15 days of treatment and at 2 weeks post treatment]
Outcome measured by a change in BSI-CV score from baseline to 2 weeks post-treatment. BSI-CV is a self-reported questionnaire with 19 items. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide.
Secondary Outcome Measures
- 17-Item Hamilton Rating Scale for Depression (HAMD-17) [Baseline, after 7 days of treatment, after 15 days of treatment and at 2 weeks post treatment]
Outcome measured by a change in HAMD-17 score from baseline to 2 weeks post-treatment.The HAMD Total Score comprises a sum of the 17 individual item scores. Each item is rated on a 3 point scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Response is defined as having a 50% or greater reduction from baseline in HAMD total score. Remission is defined as having a HAMD total score of ≤7
Other Outcome Measures
- Magnetic Resonance Imaging (MRI) [Baseline, after 15 days of treatment]
resting-state functional MRI
- near-infrared imaging technology (fNIRS) [Baseline, after 7 days of treatment, after 15 days of treatment and at 2 weeks post treatment]
task-state fNIRS
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18-60 years
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meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
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have a score > 17 on the HAMD-17
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have a score ≥ 6 on the BSI-CV
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right- handedness
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physical examination, medical history, vital signs, blood routine, liver and kidney function, ECG, EEG and other indicators are normal
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are voluntary and competent to consent to treatment
Exclusion Criteria:
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People with a history of severe physical illness and depression caused by psychoactive substances and non-dependent substances
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Patients with metal or electronic equipment, such as intracranial metal foreign bodies, cochlear implants, pacemakers and brace, etc.
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Risk of seizures, previous central nervous system diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of abnormal brain structure, or family history of epilepsy
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Acute suicide
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have psychotic symptoms and need to use antipsychotic drugs
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receive ECT treatment within 2 months
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pregnant, breastfeeding or planning to become pregnant during the trial
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refuses to sign the consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | XijingH | Xi'an | Shaanxi | China | 710032 |
Sponsors and Collaborators
- Xijing Hospital
Investigators
- Study Chair: HuaNing WANG, PhD, Xijing Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY20202066-F-1