Effect of Anodal Transcranial Direct Current Stimulation on the Intensity of Post-dural Puncture Headache: Results of Two Randomized Sham Controlled Trials

Introduction: Post-dural puncture headache (PDPH) is a common complication of diagnostic lumbar puncture (LP), often leading to extended hospitalization and additional medication use. Clinical studies have shown that anodal transcranial direct current stimulation (a-tDCS) is effective against migraine, and thus we decided to assess whether a-tDCS was also effective in treating and preventing PDPH. Methods: In two independent, randomized, monocentric controlled trials (RCTs), we enrolled 97 hospitalized participants who underwent LP for diagnostic purposes. Patients were randomized to receive either active a-tDCS or sham tDCS over the dominant primary motor cortex (M1) in a therapeutic tDCS (Th-tDCS) or preventive tDCS (Pr-tDCS) study. In the two trials, the primary outcome was the severity of PDPH measured using the Visual Analogue Scale (VAS) for pain. Secondary outcomes included the Brief Pain Inventory (BPI) to evaluate other pain-related symptoms associated with LP. Results: In the Th-tDCS study, significant differences between groups were observed after tDCS in the VAS (F = 17.011, p < 0.001), as well as in BPI intensity (F = 17.006, p < 0.001) and BPI interference (F = 14.730, p < 0.001). Moreover, in the Pr-tDCS study, VAS analysis showed a significant time × group interaction (F = 6.918, p = 0.002). Significant differences were also observed in BPI intensity (F = 17.866, p < 0.001) and BPI interference (F = 15.520, p < 0.001). Conclusions: Our findings suggest that a-tDCS may effectively prevent and treat PDPH and alleviate other pain-related symptoms associated with LP. Encouraging results have emerged for the use of a-tDCS in patients undergoing LP, in both experimental research designs (Th-tDCS and Pr-tDCS). A non-invasive brain stimulation (NIBS) technique, such as a-tDCS, could have a therapeutic and preventive effect on pain resulting from a LP. Trial Registration: ClinicalTrials.gov (ID: NCT06640634) retrospectively registered on October 8, 2024.