Neuronavigation Guided iTBS With Personalized Target for Depression

Air Force Military Medical University of People's Liberation Army

Status and phase: Invitation-only; Phase 2

Conditions: Depression

Treatments: Combination Product: sham iTBS combined with antidepressants; Combination Product: iTBS combined with antidepressants

Study type: Interventional

Funder types: Other

Identifiers

NCT05577481

XJLL-KY20222111

Details and patient eligibility

About

The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 60 years old
• Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
• Meet the threshold on the total HAMD17 score of >17 at both screening and baseline visits
• Able to provide informed consent

Exclusion criteria

• any other current or past psychiatric axis-I or axis-II disorders
• severe physical illnesses
• psychotic symptoms, alcohol or drug abuse
• A history of neurological disorders including seizure, cerebral trauma
• MRI evidence of structural brain abnormalities
• Contraindications to MRI and rTMS
• Acute suicide
• Female that is pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups

functional MRI-guided iTBS(sham group)

Sham Comparator group

Description:

The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).

Treatment:

Combination Product: sham iTBS combined with antidepressants

functional MRI-guided iTBS (pgACC-DLPFC)

Experimental group

Description:

The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).

Treatment:

Combination Product: iTBS combined with antidepressants