NCT05938673

Effects of rTSMS Associated With Treadmill Training in Patients With Parkinson's Disease

Effects of Repetitive Trans Spinal Magnetic Stimulation Associated With Treadmill Gait Training on Gait Disorders in Patients With Parkinson's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Gait changes appear and become the main cause of disability, loss of independence, falls, fractures and reduced quality of life for patients with Parkinson Disease. Optimal gait management is complex and challenging. Some characteristics, such as gait variability, postural instability, and postural changes, continue to worsen over time despite optimal dopaminergic treatment, suggesting that additional interventions are needed. Given the physiology of gait and postural control in humans, spinal cord stimulation is a potential target for neuromodulatory approaches to gait and postural disorders. Repetitive transspinal magnetic stimulation ( rTSMS) has attracted a lot of attention, due to the possibility of modulating motor and sensory networks in a non-invasive way, activating directly the dorsal ascending pathways and projecting to the thalamic nuclei, cerebral cortex, and brainstem nuclei, thus stimulating descending motor tracts and interrupting aberrant oscillatory activity in corticobasal nuclei circuits. The combination of non-invasive neuromodulation with other therapies can enhance the effectiveness of rehabilitation, increasing plasticity and clinical efficacy, offering a greater and more sustained effect than either therapy alone.It's recommended that patients with PD perform a specific exercise for walking, such as treadmill training (tt), that imposes an external rhythm and concentration of attention on gait, acting as an external cue or marker, promoting a more stable gait, reducing gait variability and decreasing risk of falls. It is proposed, in this study, to develop a new treatment model through the integration of two promising and complementary approaches to improve gait disorders in PD: rTSMS and tt. Thus, the investigators idealized the realization of the first randomized, double-blind, placebo-controlled, parallel, phase III clinical trial that will evaluate the efficacy of tt associated with rTSMS in patients with PD.

Detailed description

The primary objective is to evaluate the effects of treadmill gait training associated with repetitive transspinal magnetic stimulation on the change in rapid gait speed in Parkinson Disease patients. The investigators hypothesize that the association of repetitive transspinal magnetic stimulation with treadmill gait training should be superior to treadmill gait training alone in improving gait symptoms in patients with PD. Additionally, will be investigated the effects of treadmill gait training associated with repetitive transspinal magnetic stimulation on comfortable gait speed; in clinical and neurophysiological measures; in motor symptoms; in activities of daily living; in the ability to walk (total distance covered); in balance performance; in time to complete the turn; in the severity of the freezing of the gait; in mobility; in the level of physical activity; in the number and fear of falls and in the perception of quality of life of patients with PD. In addition, the possible side effects of the intervention will be evaluated.

Conditions

• Parkinson Disease
• Gait Disorders, Neurologic

Interventions

Type	Name	Description
OTHER	Active stimulation- intermittent theta-burst (iTBS) stimulation	During active stimulation, patients will receive intermittent theta-burst (iTBS) stimulation in T2-T3 toracic region while seated using a circular magnetic coil positioned at 90º, handle facing to the right, connected to a magnetic stimulator.Each participant will receive a total of 1,200 rTsMS pulses at 120% of resting motor threshold, determined by abdominal muscle contractions. In 3 minutes and 58 seconds, 20 trains with 20 bursts and each burst with 3 pulses at 50 Hz repeated at 5Hz with an intertrain interval of 8 seconds will be applied.Immediately after, participants will proceed with 30 minutes of treadmill training, starting at 80% of the comfortable walking speed. Progressive speed increments of 0.2 km/h will be performed every 5 minutes as tolerated. The intensity of the exercise will be adjusted to the patient's tolerance and maintained between light to moderate intensity.
OTHER	Sham stimulation	During sham stimulation, a circular magnetic coil will be positioned in the T2-T3 toracic region disconnected to the stimulation device and the active coil will be positioned about 15 cm behind the patient, away from his field of vision, to provide sound stimulus. To create a sensation of muscle contraction and impression of active stimulation, the group will be submitted to the sensory effect of transcutaneous electrical neurostimulation (TENS) for 5 minutes, with surface electrodes placed in parallel at the T2-T3, with the parameters (80Hz,150ms, 60 mA).Immediately after, participants will proceed with 30 minutes of treadmill training, starting at 80% of the comfortable walking speed. Progressive speed increments of 0.2 km/h will be performed every 5 minutes as tolerated. The intensity of the exercise will be adjusted to the patient's tolerance and maintained between light to moderate intensity.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-06-01
• Completion: 2025-01-01
• First posted: 2023-07-10
• Last updated: 2026-03-02

Locations

1 site across 1 country: Brazil