Abstract
Background: Pilot open-label application of high-frequency repetitive transcranial magnetic stimulation (rTMS) with H-coil in Parkinson's Disease (PD) have shown promising results.Objective: To evaluate safety and efficacy of high-frequency rTMS with H-coil in PD in a double-blind, placebo-controlled, randomized study.Methods: Sixty patients with PD were randomized into 3 groups: M1-PFC (real stimulation on primary motor-M1 and pre-frontal cortices-PFC), M1 (real rTMS on M1, sham on PFC), Sham (apparent stimulation). Primary outcome was baseline-normalized percent improvement in UPDRS part III OFF-therapy at the end of treatment (12 rTMS sessions, 4 weeks). Secondary outcomes were improvement in UPDRS part III sub-scores, timed tests, and neuropsychological tests. Statistical analysis compared improvement following real and sham stimulation at the end of the protocol using either a t-test or a Mann-Whitney test.Results: All patients tolerated the treatment and concluded the study. One patient from M1-PFC group was excluded from the analysis due to newly discovered uncontrolled diabetes mellitus. No serious adverse effect was recorded. At the end of treatment, patients receiving real rTMS (M1-PFC and M1 combined) showed significantly greater improvement compared to sham in UPDRS part III total score (p = 0.007), tremor subscore (p = 0.011), and lateralized sub-scores (p = 0.042 for the more affected side; p = 0.012 for the less affected side). No significant differences have been oserved in safety and efficacy outcomes between the two real rTMS groups. Notably, mild, not-distressing and transient dyskinesias occurred in 3 patients after real rTMS in OFF state.Conclusions: The present findings suggest that high-frequency rTMS with H-coil is a safe and potentially effective procedure and prompt larger studies for validation as add-on treatment in PD.
Highlights
The development of invasive therapeutic options such as deep brain stimulation has opened new perspectives but remains a niche procedure [1]
There were no significant difference in baseline features between groups, except for axial score which was significantly higher in Sham compared to Merged group (10.8 ± 4.0 vs. 9.7 ± 4.6, p = 0.044) and was not further analyzed
In three patients, clinical examination performed OFF-drug at T2, showed the presence of involuntary movements, lasting about 15 min after the end of the stimulation, similar to those experienced by the patients when in the ON state
Summary
The development of invasive therapeutic options such as deep brain stimulation has opened new perspectives but remains a niche procedure [1]. Non-invasive neuromodulation techniques, such as repetitive transcranial magnetic stimulation (rTMS), have the potential to play a role in Parkinson’s disease (PD) therapy [2]. A 2018 meta-analysis of placebocontrolled trials found a significant beneficial effect on motor symptoms of high-, but not low-frequency rTMS [5, 6]. An open-label pilot study performed by our group showed that high-frequency rTMS stimulation of bilateral M1 and PFC with H-coil might serve as a safe and effective treatment for PD [13]. In the current study we aimed at further exploring the therapeutic effects and safety profile of rTMS with H coil on PD motor symptoms in a doubleblind, placebo-controlled trial. Pilot open-label application of high-frequency repetitive transcranial magnetic stimulation (rTMS) with H-coil in Parkinson’s Disease (PD) have shown promising results
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
