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Two-week active tsDCS improved RLS symptoms and neurophysiological measures versus sham in a small RCTCould a two-week treatment ease restless legs and improve sleep for patients?

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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.

Imagine lying in bed, unable to relax because your legs feel uncomfortable and won't stop moving. For people with restless legs syndrome, this struggle makes sleep nearly impossible. A new study looked at whether a specific type of electrical stimulation could help. Participants received active stimulation for two weeks, while others received a sham, or fake, treatment that felt the same but had no electrical effect.

The results were clear. Those who received the real treatment saw a much larger drop in their symptom scores compared to the group that received the sham. They also reported better sleep quality. Beyond just feeling better, the study measured brain and nerve signals, finding that the active treatment changed these signals in ways that suggest it is working on the nervous system.

No safety problems were reported during the short study period, and no one had to stop the treatment early. Yet, we must be careful. This trial included only 30 patients, which is a small number for such a serious condition. Because the study was so short, we do not know if these benefits last for months or years. The specific settings used for the electrical stimulation were also not detailed, making it hard to repeat exactly.

While this is encouraging news for those seeking relief, it is not yet a guaranteed cure. More research with larger groups of people is needed to confirm these findings and ensure long-term safety. Until then, this study offers a hopeful glimpse into new ways to treat restless legs, but it does not replace current standard options.

What this means for you:
A two-week electrical treatment improved symptoms and sleep in a small study, but larger trials are needed to confirm safety and lasting benefits.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
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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