Clinical trial NCT04653337: Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression
Official title: Research on Efficacy and Safety of Robot-assisted rTMS Based on Neuroimaging Navigation for the Treatment of Depressive Patients With Suicidal Ideation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Suicidal Ideation
Depression
Keywords: Suicidal Ideation
Depression
Neuronavigation
robot-assisted rTMS
rTMS
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 18-60 years
* meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
* have a score \> 17 on the HAMD-17
* have a score ≥ 6 on the BSI-CV
* right- handedness
* physical examination, medical history, vital signs, blood routine, liver and kidney function, ECG, EEG and other indicators are normal
* are voluntary and competent to consent to treatment

Exclusion Criteria:

* People with a history of severe physical illness and depression caused by psychoactive substances and non-dependent substances
* Patients with metal or electronic equipment, such as intracranial metal foreign bodies, cochlear implants, pacemakers and brace, etc.
* Risk of seizures, previous central nervous system diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of abnormal brain structure, or family history of epilepsy
* Acute suicide
* have psychotic symptoms and need to use antipsychotic drugs
* receive ECT treatment within 2 months
* pregnant, breastfeeding or planning to become pregnant during the trial
* refuses to sign the consent

Primary outcomes:
measure: Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score
timeFrame: Pre-treatment to immediately post treatment (on day 5)
Secondary outcomes:
measure: Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score
timeFrame: Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
measure: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
timeFrame: Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
measure: Change in the Beck Depression Inventory (BDI)
timeFrame: Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
measure: Change in the 6-Item Hamilton Rating Scale for Depression (HAMD-6) Score
timeFrame: Pre-treatment to immediately post treatment (on day 5) and 2 weeks, 4 weeks post-treatment
Other outcomes:
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Baseline, Within 2 days post-treatment
measure: near-infrared imaging technology (fNIRS)
timeFrame: Baseline, Within 2 days post-treatment
Locations:
city: Xi'an
country: China
facility: XijingH
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: HuaNing WANG, PhD
role: STUDY_CHAIR
References: