Movement disorders : official journal of the Movement Disorder Society · 2025
Spinal Cord Stimulation Failed to Improve Parkinson's Disease Symptoms in Randomized Crossover Double-Blinded Evaluation.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Carra Rafael Bernhart, Garcia Lucas Ávila Lessa, Menezes Janaina Reis, Capato Tamine, Santos Francielle, Barbosa Egberto Reis, Duarte Kleber Paiva, Godinho Fabio, Teixeira Manoel Jacobsen, de Andrade Daniel Ciampi, Cury Rubens Gisbert
Аннотация
BACKGROUND: Epidural electrical spinal cord stimulation has been studied for more than a decade for Parkinson's disease symptoms, but compelling evidence for its effectiveness is still lacking.
OBJECTIVE: The aim of this study was to evaluate the effectiveness of spinal cord stimulation in Parkinson's disease.
METHODS: Participants had Parkinson's disease diagnosis, gait impairment and freezing of gait, and no pain. Paddle electrodes were implanted at the T2-T4 level. After 6 months of parameter selection, subthreshold and sham stimulation were compared through a double-blinded randomized evaluation and further compared with suprathreshold stimulation. A second 6- to 8-month period of parameter adjustment and a final long-term open evaluation followed. Outcomes were determined via Timed Up and Go (TUG), Movement Disorders Society Unified Parkinson's Disease Scale (MDS UPDRS) Part III, Mini BESTest, New Freezing of Gait Questionnaire, Parkinson's Disease Questionnaire 39, Fall Efficiency Scale International, and accelerometer-based gait analysis. Functional magnetic resonance imaging was also performed during the double-blind evaluation period.
RESULTS: This study was terminated for futility after eight patients underwent implantation and seven completed double-blind evaluations. TUG duration ON stimulation was median 11.59 (19.7-10.9) seconds on medication and 24.49 (48.1-13.7) seconds off medication, which was not statistically different from sham with 12.38 (13.7-11.8) and 16.93 (30-14.4) seconds on respective medication status. Likewise, no significant differences were found for MDS UPDRS Part III scores, respectively, ON active stimulation for 29 (33.5-23) and 42 (51-40) seconds and on sham 28 (30.5-26) and 50 (51.5-44) seconds. No effect from stimulation was identified in any other outcome.
CONCLUSIONS: No effect of spinal cord stimulation in Parkinson's disease symptoms was identified. © 2025 International Parkinson and Movement Disorder Society.
OBJECTIVE: The aim of this study was to evaluate the effectiveness of spinal cord stimulation in Parkinson's disease.
METHODS: Participants had Parkinson's disease diagnosis, gait impairment and freezing of gait, and no pain. Paddle electrodes were implanted at the T2-T4 level. After 6 months of parameter selection, subthreshold and sham stimulation were compared through a double-blinded randomized evaluation and further compared with suprathreshold stimulation. A second 6- to 8-month period of parameter adjustment and a final long-term open evaluation followed. Outcomes were determined via Timed Up and Go (TUG), Movement Disorders Society Unified Parkinson's Disease Scale (MDS UPDRS) Part III, Mini BESTest, New Freezing of Gait Questionnaire, Parkinson's Disease Questionnaire 39, Fall Efficiency Scale International, and accelerometer-based gait analysis. Functional magnetic resonance imaging was also performed during the double-blind evaluation period.
RESULTS: This study was terminated for futility after eight patients underwent implantation and seven completed double-blind evaluations. TUG duration ON stimulation was median 11.59 (19.7-10.9) seconds on medication and 24.49 (48.1-13.7) seconds off medication, which was not statistically different from sham with 12.38 (13.7-11.8) and 16.93 (30-14.4) seconds on respective medication status. Likewise, no significant differences were found for MDS UPDRS Part III scores, respectively, ON active stimulation for 29 (33.5-23) and 42 (51-40) seconds and on sham 28 (30.5-26) and 50 (51.5-44) seconds. No effect from stimulation was identified in any other outcome.
CONCLUSIONS: No effect of spinal cord stimulation in Parkinson's disease symptoms was identified. © 2025 International Parkinson and Movement Disorder Society.