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

University of Sao Paulo General Hospital

Status: Completed

Conditions: Gait Disorders, Neurologic; Parkinson Disease

Treatments: Other: Sham stimulation; Other: Active stimulation- intermittent theta-burst (iTBS) stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05938673

57119022.4.1001.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Patients with unstabilized psychiatric comorbidities;
• Individuals who have other neurological disorders, musculoskeletal, orthopedic, cardiovascular and respiratory disorders that may affect the ability to walk on the treadmill will be excluded.
• Individuals with labyrinthine problems, using medication that may interfere with balance and performance in tests and treadmill training will be excluded.
• Individuals who have undergone deep brain stimulation surgery or epidural spinal cord stimulation will be excluded.
• Patients with uncontrolled infection or other uncontrolled pre-existing medical conditions (eg uncontrolled diabetes, high blood pressure, symptomatic lung or heart disease);
• Concomitant treatment with other experimental drugs;
• Pregnant or breastfeeding women.
• Presence of chronic low back and lower limb pain.
• Patients who cannot walk without assistance (cane, crutch, walker) or help from another person.
• Patients with metal implants and a cardiac pacemaker.
• Patient with a history of neurosurgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Sham repetitive transpinal magnetic stimulation

Sham Comparator group

Description:

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.

Treatment:

Other: Sham stimulation

Active repetitive transpinal magnetic stimulation

Active Comparator group

Description:

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.

Treatment:

Other: Active stimulation- intermittent theta-burst (iTBS) stimulation