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

Air Force Military Medical University of People's Liberation Army

Status and phase: Enrolling; Phase 2

Conditions: Suicidal Ideation; Depression

Treatments: Combination Product: Robot-assisted accelerated iTBS-1800 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Combination Product: Robot-assisted accelerated iTBS-600 combined with serotonin-norepinephrine reuptake inhibitors(SNRIs); Combination Product: Sham accelerated iTBS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)

Study type: Interventional

Funder types: Other

Identifiers

NCT04653337

KY20202066-F-1

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 3 patient groups

Robot-assisted accelerated iTBS-1800 and Antidepressants

Experimental group

Description:

MDD patients with suicidal ideation will receive antidepressants combined with robot-assisted accelerated iTBS-1800(10 sessions per day over 5 consecutive days). This group is in order to determine the safety, tolerability and feasibility of accelerated iTBS protocol.

Treatment:

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

Robot-assisted accelerated iTBS-600 and Antidepressants

Active Comparator group

Description:

MDD patients with suicidal ideation will receive antidepressants combined with robot-assisted accelerated iTBS-600(6 sessions of iTBS with 30 min interval per day over 5 consecutive days).

Treatment:

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

Sham accelerated iTBS-600 and Antidepressants

Sham Comparator group

Description:

MDD patients with suicidal ideation and depression will receive antidepressants combined with sham accelerated iTBS-600(6 sessions of sham iTBS with 30 min interval per day over 5 consecutive days).

Treatment:

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