Two-week active tsDCS improved RLS symptoms and neurophysiological measures versus sham in a small RCT.
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Key Takeaway
Consider cautious interpretation of tsDCS benefits for RLS given small sample size and missing safety data.
This randomized controlled trial investigated the effects of active transcutaneous spinal cord direct current stimulation (tsDCS) versus sham stimulation in patients with restless legs syndrome. The study enrolled 30 participants and administered the intervention for two consecutive weeks, with outcomes assessed after 14 days of treatment. Specific stimulation parameters, such as current intensity and session duration, were not reported.
Primary and secondary outcomes included the International Restless Legs Syndrome Rating Scale (IRLS-RS) score, Pittsburgh Sleep Quality Index (PSQI) score, H-reflex from the gastrocnemius muscle, and transcranial magnetic stimulation-induced motor evoked potentials (TMS-MEP). The active tsDCS group demonstrated a mean IRLS-RS score improvement of 12.20 ± 5.68, compared to 1.20 ± 3.59 in the sham group (t = 6.337, p = 0.000). Similarly, PSQI scores improved by 4.60 ± 2.72 in the active group versus 0.40 ± 2.26 in the sham group (t = 4.598, p < 0.001). Neurophysiological measures also favored the active group, showing a prolonged cortical silent period, increased MEP amplitude after rest, and a reduced paired H-reflex ratio.
Safety and tolerability data were not reported, and no adverse events or discontinuations were documented in the available text. Key limitations include the small sample size of 30 participants, the absence of baseline severity scores (only change scores were provided), and the lack of long-term follow-up. The study does not explicitly claim causation, noting that improvements are associated with the intervention. Consequently, the clinical relevance of these results remains uncertain pending further research with larger cohorts and comprehensive safety reporting.
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View Original Abstract ↓
STUDY OBJECTIVES: This study explored the changes in cortical and spinal excitability in patients with restless legs syndrome (RLS) induced by transcutaneous spinal cord direct current stimulation (tsDCS), thereby revealing the neural electrophysiological mechanism underlying tsDCS-mediated improvements in RLS symptoms.
METHODS: Thirty patients with RLS were randomly assigned to active RLS-tsDCS group or sham stimulation group for 2 consecutive weeks. Symptom severity and sleep quality were assessed using the International Restless Legs Syndrome Rating Scale (IRLS-RS) and the Pittsburgh Sleep Quality Index (PSQI). Electrophysiological parameters, including the H-reflex from the gastrocnemius muscle and transcranial magnetic stimulation-induced motor evoked potentials (TMS-MEP), were performed to assess changes in cortical and spinal excitability before and after treatment.
RESULTS: The main analysis showed that the improvement in IRLS-RS score in the RLS-tsDCS group (Δ = 12.20 ± 5.68) was significantly greater than that in the sham stimulation group (Δ = 1.20 ± 3.59, t = 6.337, p = 0.000). PSQI score improvement was greater in the RLS-tsDCS group (Δ = 4.60 ± 2.72) compared to the sham stimulation group (Δ = 0.40 ± 2.26; t = 4.598, p < 0.001). After 14 days tsDCS treatments, the RLS-tsDCS group exhibited a significantly prolonged cortical silent period, a significant increase in MEP amplitude after 15min rest during movement tasks, and a significant reduction in the paired H-reflex ratio (H2/H1) in the lower limbs compared to baseline. No significant changes were observed in any neurophysiological parameters in the sham stimulation group.
CONCLUSION: Our research results indicated that anodal tsDCS can significantly improve the clinical symptoms of RLS patients and reduce the IRLS-RS and PSQI scores. This may be achieved through tsDCS enhancing the cortical inhibitory function and thereby reducing spinal neuronal excitability.
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