Bilateral Repetitive Transcranial Magnetic Stimulation With the H-Coil in Parkinson's Disease: A Randomized, Sham-Controlled Study

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.

Devices and Technology in Transcranial Magnetic Stimulation: A Systematic Review

“…This coil can be customized to produce focalized stimulation in deep regions of the brain with little effect in cortical zones; however, it still required more work to fully determine its practical usefulness in clinical practice. After the first proposal in 2002, many variations of the first design have been suggested, for different deep TMS applications [ 111 ], these being the therapy of psychiatric and neurological diseases the most common [ 112 , 113 ].…”

Effects of Repetitive Transcranial Magnetic Stimulation on Motor Symptoms in Parkinson’s Disease: A Meta-Analysis

“…Finally, 32 articles were included according to the pre-determined inclusion criteria (Figure 1) (Table 1 and Table 2). 10-43…”

“…Several controlled and uncontrolled studies have validated the therapeutic effect of rTMS on PD, 10-43 especially on motor symptoms. However, most of them have involved small sample sizes and vary greatly in outcome measures, inclusion/exclusion criteria, methods of sham-TMS, and monitoring safety and tolerability.…”

Safety of Deep Repetitive Transcranial Magnetic Stimulation (drTMS) against Medical Refractory Symptoms in Parkinson Syndromes: First German Real-World Data with a Specific H5 Coil

“…One advantage of the H-coil compared to the figure-of-eight coil is the slower decay of magnetic fields, which therefore reach deeper and stimulate a larger proportion of the brain [6][7][8]. Furthermore, the H5 coil in particular, designed for PD (Brainsway Inc., Jerusalem, Israel), can be used to bilaterally target motor cortex regions and/or the prefrontal cortex [9][10][11]. This is in accordance with findings from rTMS studies, which suggest that bilateral stimulation has the highest efficacy on motor symptoms in PD [5].…”