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. 2024 Feb 21;25(1):134.
doi: 10.1186/s13063-024-07976-3.

Efficacy of functional magnetic resonance imaging-guided personalized repetitive transcranial magnetic stimulation (fMRI-rTMS) in depressive patients with emotional blunting: study protocol for a randomized controlled trial

Yuyu Zhang  1 , Nailong Tang  1   2 , Lei Lei  1 , Runxin Lv  1 , Yaochi Zhang  1 , Nian Liu  1 , Haixia Chen  1 , Min Cai  3 , Huaning Wang  4
Affiliations

Efficacy of functional magnetic resonance imaging-guided personalized repetitive transcranial magnetic stimulation (fMRI-rTMS) in depressive patients with emotional blunting: study protocol for a randomized controlled trial

Yuyu Zhang et al. Trials. .

Abstract

Background: Emotional blunting is a symptom that has always been present in depressed patients. Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective supplementary therapy for treating depression. However, the effectiveness and brain imaging processes of functional magnetic resonance imaging-guided personalized rTMS (fMRI-rTMS) in the treatment of depression with emotional blunting have not been observed in randomized controlled trials.

Methods: This study is a randomized, controlled, double-blind, and single-center clinical trial in which 80 eligible depressed patients with emotional blunting will be randomly assigned to two groups: a functional magnetic resonance imaging-guided personalized rTMS (fMRI-rTMS) group and a control group. Individuals in the fMRI-rTMS group (n = 40) will receive high-frequency rTMS (10 Hz, 120% MT). The main target of stimulation will be the area most relevant to the functional connectivity of the right medial prefrontal cortex (mPFC) and amygdala. The control group (n = 40) will receive sham stimulation, with a coil flipped to 90 degrees relative to the vertical scalp. All patients will receive 15 consecutive days of treatment, with each session lasting half an hour per day, followed by 8 weeks of follow-up. The primary outcome is the comparison of Oxford Depression Questionnaire (ODQ) scores between these two groups at different time points. The secondary outcomes include evaluating other clinical scales and assessing the differences in brain imaging changes between the two groups before and after treatment.

Discussion: This trial aims to examine the effects of functional magnetic resonance imaging-guided personalized rTMS (fMRI-rTMS) intervention on depressed patients experiencing emotional blunting and to elucidate the potential mechanism behind it. The results will provide new evidence for using fMRI-rTMS in treating depression with emotional blunting in the future.

Trial registration: ClinicalTrials.gov INCT05555940. Registered on 13 September 2022 at http://clinicaltrials.gov .

Keywords: Depression; Emotional blunting; FMRI-rTMS; Randomized controlled trial.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the trail design. rTMS, repetitive transcranial magnetic stimulation; fMRI-rTMS, functional magnetic resonance imaging-guided personalized rTMS
Fig. 2
Fig. 2
rTMS, repetitive transcranial magnetic stimulation; fMRI-rTMS, functional magnetic resonance imaging-guided personalized rTMS; MRI, magnetic resonance imaging; ODQ, Oxford Depression Questionnaire; MADRS, Montgomery-Asberg Depression Rating Scale; HAMD-17, Hamilton Depression Scale-17; BSI-CV, Beck Scale for Suicide Ideation-Chinese Version; BDI, Beck Depression Inventory; SSRS, Social Support Rating Scale; LES, Life Event Scale; ISI, Insomnia Severity Index; THINK-it, Cognitive function test; PDQ-D, Perceived Deficit Questionnaire for Depression; CGI, Clinical Global Impressions
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