Effects of Magnetic Stimulation of the Dorsal Spinal Cord on Gait in Patients With Parkinson´s Disease and Deep Brain Stimulation — TMS  

Parkinson Disease Clinical Trial

Official title: Effects of Magnetic Stimulation of the Dorsal Spinal Cord on Gait in Patients With Parkinson´s Disease and Deep Brain Stimulation

Status Recruiting

Clinical Trial Summary

Gait disorders are symptoms that significantly compromise the quality of life and functionality of patients with Parkinson's disease (PD). When they are not responsive to drug dopaminergic therapy and deep brain stimulation (DBS), the management of these symptoms is a challenge in clinical practice. Although deep brain stimulation is useful in the motor symptoms of Parkinson's disease, gait symptoms remains a challenge in patients undergoing this therapy. This is because, in addition to adjustments in the DBS programming not adding evident benefit in some patients with gait disorders, motor symptoms tend to progress over the years. In this context, spinal cord invasive electrical stimulation was proposed as a potential and effective therapy in a group of patients with PD who presented with gait impairment. More recently, the application of transcutaneous magnetic stimulation of the spinal cord has emerged as a possible therapeutic option, as it could stimulate neural elements in a non-invasive way. The general objective will be to study the effect of transcutaneous magnetic stimulation of the spinal cord on gait in PD patients with deep brain stimulation refractory to dopaminergic therapy. The method of the present study will be a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial that will evaluate the efficacy of transcutaneous magnetic stimulation of the spinal cord in patients with PD and deep brain stimulation who present gait disorders refractory to dopaminergic therapy. The primary outcome will be the change in gait speed between pre-stimulation and post-stimulation conditions between the two groups (active and placebo) assessed using the Timed Up and Go Test (TUG). Secondary outcomes will be the effects of stimulation on other gait measures (speed, step length, stride length, cadence, step width, sway time, support time and the presence of blocks), other motor symptoms (Unified Parkinson's Disease Rating Scale), cognitive alterations, quality of life and side effects. Statistical analysis will be performed using ANOVA for repeated measures and 38 patients will be included. The expected results are supported by transcutaneous magnetic stimulation of the spinal cord, which may improve gait disorders in participants with PD and DBS.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT05008289
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Contact: Rubens G Cury, PhD
• Phone: +55 (11) 97283-8184
• Email: rubens_cury@usp.br
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2020
• Completion date: November 28, 2024