Discover how the innovative use of transcranial direct current stimulation (tDCS) offers new hope for chronic headache relief in adults battling systemic lupus erythematosus, as revealed by the groundbreaking SHADE clinical trial.
– by James
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Effectiveness of transcranial direct current stimulation (tDCS) as adjunctive treatment for chronic headache in adults with clinically stable systemic lupus erythematosus (SHADE): a randomised double-blind multiarm sham controlled clinical trial.
Estiasari et al., BMJ Open 2023
DOI: 10.1136/bmjopen-2023-076713
New Information:
The SHADE trial is a new study designed to evaluate the effectiveness of transcranial direct current stimulation (tDCS) as a treatment for chronic headaches in patients with systemic lupus erythematosus (SLE). This trial is significant as it aims to establish a standard protocol for tDCS in this context.
Importance:
Chronic headache is a common but often overlooked symptom of SLE that can severely impact quality of life. Current treatments are limited, and the SHADE trial explores a non-invasive alternative that could potentially offer relief without the side effects associated with pharmacotherapy.
Contribution to Literature:
The trial is unique in its approach, as it compares the effects of tDCS when administered at different brain locations. It is a randomized, double-blind, multiarm, sham-controlled trial with a 1:1:1:1 allocation ratio among 88 subjects. The primary endpoint is the reduction in the number of headache days, with secondary endpoints including headache intensity, quality of life, sleep quality, depression levels, and analgesic use.
Methodology:
Participants will be monitored using various tools such as a headache diary, quality of life questionnaires, and sleep and depression indices. The trial will use intention-to-treat analysis to identify the most effective electrode placement for tDCS.
Ethical Considerations:
The study has received ethical approval from the Institutional Review Board of the Faculty of Medicine at Universitas Indonesia, and results will be disseminated through peer-reviewed journals. The trial is registered under NCT05613582.