• LapaJorge Dornellys da SilvaJDDSLIM-62, Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil. Electronic address: dr.dornellys@hotmail.com., Pedro Henrique Martins da Cunha, Manoel Jacobsen Teixeira, Brito MedeirosVitor MacedoVMLIM-62, Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Ana Mércia Fernandes, Silva de MoraisAdriano DonizethADLIM-62, Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil., Thomas Graven-Nielsen, Rubens Gisbert Cury, and Daniel Ciampi de Andrade.
• LIM-62, Pain Center, Department of Neurology, University of São Paulo, São Paulo, Brazil. Electronic address: dr.dornellys@hotmail.com.
• Neuromodulation. 2023 Jun 1; 26 (4): 840849840-849.

Background And AimsNociception is the most prevalent pain mechanism in Parkinson disease (PD). It negatively affects quality of life, and there is currently no evidence-based treatment for its control. Burst spinal cord stimulation has been used to control neuropathic pain and recently has been shown to relieve pain of nociceptive origin. In this study, we hypothesize that burst transspinal magnetic stimulation (bTsMS) reduces nociceptive pain in PD.Materials And MethodsTwenty-six patients were included in a double-blind, sham-controlled, randomized parallel trial design, and the analgesic effect of lower-cervical bTsMS was assessed in patients with nociceptive pain in PD. Five daily induction sessions were followed by maintenance sessions delivered twice a week for seven weeks. The primary outcome was the number of responders (≥ 50% reduction of average pain intensity assessed on a numerical rating scale ranging from 0-10) during the eight weeks of treatment. Mood, quality of life, global impression of change, and adverse events were assessed throughout the study.ResultsTwenty-six patients (46.2% women) were included in the study. The number of responders during treatment was significantly higher after active than after sham bTsMS (p = 0.044), mainly owing to the effect of the first week of treatment, when eight patients (61.5%) responded to active and two (15.4%) responded to sham bTsMS (p = 0.006); the number needed to treat was 2.2 at week 1. Depression symptom scores were lower after active (4.0 ± 3.1) than after sham bTsMS (8.7 ± 5.3) (p = 0.011). Patients' global impressions of change were improved after active bTsMS (70.0%) compared with sham bTsMS (18.2%; p = 0.030). Minor adverse events were reported in both arms throughout treatment sessions. One major side effect unrelated to treatment occurred in the active arm (death due to pulmonary embolism). Blinding was effective.ConclusionBTsMS provided significant pain relief and improved the global impression of change in PD in this phase-II trial.Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT04546529.Copyright © 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.

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