Objective: To describe real-world use, tolerability, and clinical response to Nidra transcutaneous afferent patterned stimulation device in moderate-to-refractory restless legs syndrome (RLS).

Background: RLS can be challenging to treat. While latest guidelines recommend gabapentin and pregabalin as first line agents, use of agonists, benzodiazepines and opiates for challenging cases continues but limited by side effects. Nidra uses tonic motor activation to stimulate the peroneal nerve to mimic movement, reducing symptoms and received a conditional recommendation with moderate certainty of evidence from the American Academy of Sleep Medicine.

Method: We present 7 cases with chronic RLS treated with Nidra. Clinical documentation was reviewed for prior treatment failures, augmentation, device initiation, perceived benefit, and adverse effects.

Results: All 7 (5 female; mean age 79 years) failed or not tolerated multiple pharmacologic therapies (carbidopa/levodopa, agonists, gabapentin, pregabalin, tramadol, methadone, benzodiazepines). Three had augmentation. Medication-related adverse effects included sedation, imbalance, gastrointestinal intolerance, sinus pressure, and cognitive fog. Device experience varied. Two patients reported meaningful symptomatic benefit with reduction in medication burden during medication taper. Two were newly initiated and undergoing stimulation titration. One reported lack of efficacy when substituting the device for agonists completely. In complex neurologic cases (PD and ataxia), the device was used adjunctively with medications without issues. One dermatologic complication occurred in a patient with severe peripheral neuropathy. Persistent insomnia and periodic limb movements remained common comorbid challenges.

Conclusion: In this small cohort, Nidra was well tolerated and showed variable but clinically meaningful benefit, particularly as adjunctive therapy or during medication reduction. Preliminary findings support feasibility in advanced age and neurologic comorbidity, though full pharmacologic substitution may be unrealistic in moderate-to-severe RLS. Persistent insomnia despite RLS improvement underscores the need for multimodal sleep management. Response heterogeneity highlights the importance of individualized selection and expectation counseling. Larger prospective studies are needed to define predictors of response and durability.

References: Winkelman JW, Berkowski JA, DelRosso LM, et al. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2025;21(1):137-152. doi:10.5664/jcsm.11390.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-real-world-case-series-of-the-nidra-transcutaneous-afferent-patterned-stimulation-device-in-moderate-to-refractory-restless-legs-syndrome/