Role of TMS in Improving the Nerve Functions in Radial, Median, and Ulnar Neuritis Among Patients with Leprosy: Study Protocol for a Randomized Controlled Trial

Abstract

Objectives: The overall aim of this RCT is to evaluate the role of Trans-cranial Magnetic Stimulation (TMS) as a new treatment approach in physiotherapy-based rehabilitation in leprosy patients. More specifically, the primary objective of this study is to study the effect of TMS in leprosy patients with median, radial, and/or ulnar neuritis from <6 months. The secondary objective is to establish TMS as a therapeutic tool to treat leprosy patients effectively. Methods: Study Population - 98 diagnosed leprosy patients with ulnar, median, and or radial nerve function impartment for <6 months duration attending the out-patient department in CSSH Subharti Hospital, Meerut. We will include clinically diagnosed leprosy patients with median, radial, and/or ulnar neuritis from <6 months. Intervention - For Group A, TMS mapping of four hand target muscles will be performed In this group, each participant will receive ten treatment sessions of 30 min with high frequency 5-Hz TMS for 2 weeks. Along with TMS, home exercise program including standard exercises will be given. For group B, only home exercise program including standard will be given. Outcome Measures - To measure the outcomes of the study, the tools used will be electromyography, nerve conduction velocity, brain derived neurotrophic factor, manual muscle testing, monofilament sensory testing, and hand dynamometry. Statistical Analysis - F test and repeated-measures ANOVA between the factors will be used for the testing of this randomized control trial study. Discussion: It was believed that the leprosy only affects the peripheral nerves without affecting the brain but recent studies showed that brain plasticity can also occur following amputation, nerve damage, or injury. It is proved in various studies stated that the damage caused by leprosy is not limited to peripheral nerve only and is the evidence for brain plasticity. It is stated in many studies that, TMS can also be used as a neuro-modulatory tool and the application of TMS leads to improved motor performance and it also induces evident changes in connectivity in the interconnected regions of the brain but no literature evidence is available on the role of TMS in leprosy. Conclusion: In our study, we will try to fill this knowledge gap on the role of TMS as a therapeutic tool in patients with leprosy.