NeuralCipher Research overview
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BackgroundGait disorders are a major cause of disability in Parkinson's disease (PD). Trans-spinal magnetic stimulation (TsMS) shows therapeutic potential, and treadmill training (TT) is widely used; however, their combined effects are unclear.ObjectivesTo investigate whether intermittent theta burst TsMS (iTB-TsMS) modulates TT effects on gait, freezing of gait (FoG), motor symptoms, and quality of life.MethodsIn this randomized, double-blind, controlled, multicenter trial, individuals with PD and gait disturbances were recruited from three Brazilian centers (June 2023-January 2025). Participants received 10 iTB-TsMS or sham sessions plus TT over 2 weeks. Primary outcome was change in fast gait speed (FGS); secondary outcomes included MDS-UPDRS II-III, comfortable gait speed, TUG with/without dual task, Mini-BESTest, 2MWT, FoG-Q, FoG-Score, 360° Turn Test, PDQ-39, FES-I, and falls/near-falls, assessed at baseline (T0) and 3 (T3), 15 (T15), 30 (T30), and 90 (T90) days post-intervention.ResultsSeventy participants were included in the modified intention-to-treat analysis. Groups differed in FGS change at T3 (AMD 0.13 m/s; 95% CI 0.05-0.21; p = 0.001; f2 = 0.06), not sustained thereafter. Between-group differences in FoG severity were observed in FoG-Q at T15 (AMD -1.46; 95% CI -2.93 to 0.00; p = 0.050), T30 (AMD -2.30; 95% CI -3.77 to -0.83; p = 0.002), and T90 (AMD -1.75; 95% CI -3.22 to -0.29; p = 0.019), with small-to-moderate effect (f2 = 0.08), and in FoG-Score at T3 (cOR 0.21; 95% CI 0.05 to 0.97; p = 0.046). At T3, MDS-UPDRS II (AMD -2.10; 95% CI -4.17 to -0.03; p = 0.047; f2 = 0.02) and near-falls (cOR 0.36; 95% CI 0.18 to 0.72; p = 0.004) differed between groups, whereas PDQ-39 mobility improved at T30 (AMD -7.38; 95% CI -13.5 to -1.28; p = 0.018; f2 = 0.02). After correction for multiple comparisons, only FGS (T3) and FoG-Q (T30) remained significant.DiscussionAmong individuals with PD and gait disturbances, adding iTB-TsMS to TT did not produce sustained benefits over TT alone. After correction for multiple comparisons, significant effects remained for FGS at T3 and FoG severity at T30, whereas other outcomes were exploratory. The protocol was safe and well tolerated. Findings are hypothesis-generating.Trial registrationClinicalTrials.gov (NCT05938673).
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