Clinical trial NCT05938673: Effects of rTSMS Associated With Treadmill Training in Patients With Parkinson's Disease
Official title: Effects of Repetitive Trans Spinal Magnetic Stimulation Associated With Treadmill Gait Training on Gait Disorders in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Keywords: Non-invasive brain stimulation
Parkinson's disease
Spinal cord stimulation
gait
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled, parallel, phase III clinical trial.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 10 meter walk test- Fast walking speed
timeFrame: 4 months
Secondary outcomes:
measure: 10 meter walk test- Confortable walking speed
timeFrame: 4 months
measure: Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Part II and III
timeFrame: 4 months
measure: Freezing of Gait Score- (FOG- SCORE)
timeFrame: 4 months
measure: 2 Minute Walk Test
timeFrame: 4 months
measure: Timed up and Go (TUG)
timeFrame: 4 months
measure: Timed up and Go Dual Task (TUG-DT)
timeFrame: 4 months
measure: Timed 360° turn test
timeFrame: 4 months
measure: Mini-Balance Evaluation Systems Test (Mini-BESTest)
timeFrame: 4 months
measure: Freezing of Gait Questionnaire (FOG-Q)
timeFrame: 4 months
measure: Falls and near falls
timeFrame: 4 months
measure: Human Activity profile (HAP)
timeFrame: 4 months
measure: Falls Efficacy Scale- International (FES-I)
timeFrame: 4 months
measure: Parkinson's Disease Questionnaire -39 (PDQ-39)
timeFrame: 4 months
measure: Non-Motor Symptoms Scale (NMSS)
timeFrame: 4 months
measure: The Parkinson Disease Pain Classification System (PD-PCS)
timeFrame: 4 months
measure: Study of motor evoked potentials (MEPS)
timeFrame: 10 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP
state: SP
Study officials:
affiliation: Hospital das Clínicas da Faculdade de Medicina da USP
name: Rubens G Cury, MD PHD
role: PRINCIPAL_INVESTIGATOR
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