This randomized clinical trial aims to compare the effects of two different trans-spinal magnetic stimulation (tsMS) application sites, cervical versus thoracic, when combined with repetitive transcranial magnetic stimulation (rTMS), on functional mobility in individuals with Parkinson's disease (PD). Participants diagnosed with PD will be randomized into two intervention groups (rTMS + cervical tsMS or rTMS + thoracic tsMS) and will undergo 10 treatment sessions. Outcomes will include functional mobility, gait speed, motor function, freeing of gait, balance, quality of life, global perceived improvement and adverse events. The study is expected to identify the most effective tsMS application site to enhance mobility and motor outcomes in PD, contributing to the optimization and standardization of tsMS protocols as an adjunct therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters.
Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters.
Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters.
Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil
RECRUITINGFunctional Mobility (Timed Up and Go Test)
Functional mobility will be assessed using the Timed Up and Go (TUG) test. Participants are instructed to stand up from a chair, walk 3 meters at a fast but safe speed, turn around, return, and sit down. The outcome is the time to complete the task (in seconds), with lower values indicating better functional mobility.
Time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention
Statatic and Dynamic Balance (Mini Balance Evaluation Systems Test - MiniBESTest)
Balance will be evaluated using the Mini Balance Evaluation Systems Test (Mini-BESTest), a validated tool for individuals with Parkinson's disease. The test includes 14 items covering anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored on a 3-point ordinal scale, with a total score ranging from 0 to 28. Higher scores indicate better balance.
Time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention
Motor function (Movement Disorder Society-Unified Parkinson's Disease Rating Scale - MDS-UPDRS)
Motor function will be assessed using Sections II (Activities of Daily Living) and III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Items are scored from 0 (normal) to 4 (severe), with lower scores indicating better motor function.
Time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention
Freezing of gait (Freezing of gait Questionnaire - FOG-Q)
Freezing of gait will be assessed using the Freezing of Gait Questionnaire (FOG-Q), a patient-reported measure that evaluates the severity and functional impact of freezing episodes during walking. Total scores range from 0 to 24, with higher scores indicating greater impairment.
Time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention
Gait speed (10 meter-walk test)
Gait speed will be measured using the 10-Meter Walk Test. Participants will walk at usual and fastest safe speeds. Time will be recorded and converted to meters per second (m/s).
Time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention
Lower limb stength (Five times sit-to-stand test)
Lower limb strength will be assessed using the Five Times Sit-to-Stand Test (5xSTS). The time to complete five repetitions will be recorded in seconds, with longer times indicating poorer performance.
Time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention
Quality of Life Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39): Total Score and Domain Scores
Quality of life will be evaluated using the Parkinson's Disease Questionnaire-39 (PDQ-39). Scores range from 0 to 100, with higher scores indicating worse quality of life. Both total and domain scores will be analyzed.
Time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention
Global Perceived Improvement (Global perceived change scale)
Global perceived improvement will be assessed using the Global Perceived Change scale, a 7-point patient-reported measure ranging from "no change" to "much better."
Time frame: At Day 10 (end of intervention)
Adverse events
Adverse events will be monitored using a standardized questionnaire for magnetic stimulation-related side effects, including headache, scalp discomfort, tingling, fatigue, nausea, and drowsiness, rated from 0 (none) to 4 (severe).
Time frame: Throughout the intervention period (10 days)
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