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

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Men and women over the age of 18;

• Participants with PD at Hoehn Yahr stages between 2 and 4 (moderate disease) while on-medication (i.e., at the time when their usual dopaminergic medication is clinically effective), whose primary symptom includes gait disturbance (score equal to or greater than 1 in subitem 2.12 of the MSD-UPDRS scale). Patients will be evaluated for the presence of freezing gait (freezing) through the Freezing of Gait Score (FOG-SCORE).

• While on on-medication, be able to walk independently for 30 meters or with a unilateral assistive device.

• Mini Mental State Examination (MMSE) score greater than or equal to 23.

• Sign the informed consent form.

Locations
Other Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo
Time Frame
Start Date: 2022-10-01
Completion Date: 2024-05-01
Participants
Target number of participants: 76
Treatments
Sham_comparator: Sham repetitive transpinal magnetic stimulation
In the Sham group a coil will be positioned in the T2-T3 thoracic 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.
Active_comparator: Active repetitive transpinal magnetic stimulation
In the Active group, the patient will receive intermittent theta burst stimulation (iTBS) in the T2-T3 region while seated using a circular magnetic coil positioned at 90º, handle facing to the right, connected to a magnetic stimulator.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital

This content was sourced from clinicaltrials.gov