TITLE: Cortico-Spinal Intermittent Theta Burst Stimulation Propelling Sensorimotor Function Recovery in Complete Spinal Cord Injury: Randomized Control Trial Protocol

Abstract

Background:Intermittent theta burst stimulation (iTBS) is a non-invasive stimulation technique to induce neuronal and synaptic plasticity. The induced cortical plasticity is imperative in the recovery of motor and sensory functions. Spinal cord injury (SCI) causes damage to neurons and results in sensorimotor dysfunction. The effect of iTBS on recovery of motor and sensory dysfunction in complete SCI (cSCI) is still elusive. This study aims to assess the effect of iTBS on cortico-spinal tract integrity, plasticity, and regaining of motor and sensory function in cSCI patients. The rationale behind using an iTBS protocol is to modify and augment the communication between spared neurons of the cortico-spinal tract and strengthen the synaptic transmission, which will improve motor function in underlying muscles. Methods: A total of 48 patients will be recruited and randomly divided into placebo and real stimulation groups. iTBS along with a rehabilitation program will be administered to the placebo and real stimulation groups. Follow-up will be done at 1 month, 2 months, and 3 months after the intervention. Result: The outcome of the study will be defined by electrophysiological parameters elicited by single and paired-pulse stimulation, ASIA score, pain, activities of daily life, quality of life, anxiety, depression, and biomarkers related to SCI. Discussion: The results of this study will uncover the effectiveness of iTBS stimulation on (i) recovery of motor and sensory function in cSCI (ii) excitability of cortico-spinal tract (iii) neurological recovery and modulation of pain (iv) cortical reorganization after injury. Intermittent theta-burst stimulation (iTBS) in conjunction with an individualized rehabilitation program may serve as an integrated strategy to rejuvenate locomotor abilities and improve the overall quality of life for people with complete spinal cord injuries (SCI). Trial Registration: The study is registered in the Clinical Trials Registry- India (CTRI) with reference number CTRI/2022/11/047038.