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Home-based low-field magnetic stimulation as an adjunctive treatment for bipolar depression: A randomized
Jiamiao Wu1, Yaqiong Li1, Yuchuan Zou1
1Beijing Key Laboratory of Intelligent Drug Research and Development for Mental Disorders; National Clinical Research Center for Mental Disorders; National Center for Mental Disorders; Beijing Anding Hospital, Capital Medical University, Beijing, China.
Home-based low-field magnetic stimulation (LFMS) showed feasibility and safety for bipolar depression (BD-D). While not improving clinician-rated scores, LFMS offered subjective symptom relief, highlighting the importance of patient-reported outcomes in neuromodulation research.
Area of Science:
- Neurology
- Psychiatry
- Biomedical Engineering
Background:
- Bipolar depression (BD-D) presents significant morbidity and suicide risk, with limited non-pharmacological treatment options.
- Low-field magnetic stimulation (LFMS) is an ultra-low intensity neuromodulation technique suitable for home-based interventions.
- This study represents the first randomized controlled trial (RCT) investigating home-based LFMS for BD-D.
Purpose of the Study:
- To evaluate the efficacy and safety of repeated home-based LFMS as an adjunctive treatment for bipolar depression.
- To compare clinician-rated and self-reported depression symptom changes between LFMS and sham stimulation groups.
- To assess the safety profile of home-based LFMS, including affective switch events.
Main Methods:
- Sixty patients with ICD-10 diagnosed bipolar depression received either active LFMS or sham stimulation twice daily for two weeks.
- Participants maintained stable lithium treatment throughout the study.
- The primary outcome was the change in clinician-rated Hamilton Depression Rating Scale-17 (HAMD-17) from baseline to Week 6. Secondary outcomes included self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR16) and safety assessments.
Main Results:
- No significant difference in clinician-rated HAMD-17 scores was observed between the LFMS and sham groups at Week 6.
- LFMS significantly improved self-reported depression scores (QIDS-SR16) at Weeks 4 and 6 compared to sham.
- No severe treatment-related adverse events were reported; mood switch events occurred in one patient in each group.
Conclusions:
- Home-based LFMS is a feasible and safe intervention for bipolar depression.
- While not superior to sham on clinician-rated measures, LFMS demonstrated potential benefits in subjective symptom improvement.
- The findings underscore the importance of incorporating subjective endpoints in neuromodulation trials for BD-D and suggest optimizing LFMS parameters for future research.
