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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS + Cervical tsMS | Experimental | Participants will receive a combined neuromodulation protocol consisting of repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex, followed by trans-spinal magnetic stimulation (tsMS) at the cervical level. |
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| rTMS + Thoracic tsMS | Experimental | Participants will receive a combined neuromodulation protocol consisting of repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex, followed by trans-spinal magnetic stimulation (tsMS) at the thoracic level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Device | Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional 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. | Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria: (i) a clinical diagnosis of Parkinson's disease confirmed by a neurologist; (ii) stable dopaminergic pharmacological treatment for at least three months; (iii) age 40 years or older; (iv) disease stage between 2.5 and 3 on the modified Hoehn and Yahr scale; (v) (v) gait impairment, defined as the occurrence of at least one freezing of gait episode per week.
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Exclusion Criteria:
(i) other neurological disorders, orthostatic hypotension, vestibular, musculoskeletal, or visual impairments that could compromise performance on the proposed assessments; (ii) other osteomuscular conditions affecting the lower limbs that interfere with mobility and functional performance; (iii) a Montreal Cognitive Assessment (MoCA) score lower than 21 points; (iv) prior surgical procedures for Parkinson's disease; or (v) contraindications to magnetic stimulation techniques, including a history of seizures or the presence of metallic implants in the neck or spinal region.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana CecĂlia Ribeiro Nascimento, Msc. student | Contact | (81) 99893-6664 | +55 | anaceciliaribeiro.n@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kátia Monte-Silva, PhD in Neurosciences | Universidade Federal de Pernambuco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Pernambuco | Recruiting | Recife | Pernambuco | Brazil |
Individual participant data will not be shared due to privacy and ethical considerations, as well as restrictions imposed by the ethics committee.
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| Cervical Trans-spinal Magnetic Stimulation | Device | Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters. |
|
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| Thoracic Trans-spinal Magnetic Stimulation | Device | Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters. |
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| 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. | 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. | 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). | 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. | 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. | 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." | 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). | Throughout the intervention period (10 days) |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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