Gait Disorders, Parkinson's Disease (PD), Spinal Cord Stimulation, Transcranial Magnetic Stimulation
Conditions
Keywords
gait disorders, spinal cord stimulation, transcranial magnetic stimulation, parkinson's disease
Brief summary
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.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters.
DEVICECervical Trans-spinal Magnetic Stimulation
Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters.
DEVICEThoracic Trans-spinal Magnetic Stimulation
Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters.
Sponsors
Universidade Federal de Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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. \-
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Mobility (Timed Up and Go Test) | Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Statatic and Dynamic Balance (Mini Balance Evaluation Systems Test - MiniBESTest) | Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention | 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. |
| Motor function (Movement Disorder Society-Unified Parkinson's Disease Rating Scale - MDS-UPDRS) | Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention | 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. |
| Freezing of gait (Freezing of gait Questionnaire - FOG-Q) | Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention | 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. |
| Gait speed (10 meter-walk test) | Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention | 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). |
| Lower limb stength (Five times sit-to-stand test) | Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention | 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. |
| Quality of Life Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39): Total Score and Domain Scores | Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention | 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. |
| Global Perceived Improvement (Global perceived change scale) | At Day 10 (end of intervention) | 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." |
| Adverse events | Throughout the intervention period (10 days) | 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). |
Countries
Brazil
Contacts
CONTACTAna Cecília Ribeiro Nascimento, Msc. student
STUDY_DIRECTORKátia Monte-Silva, PhD in Neurosciences
Universidade Federal de Pernambuco
Outcome results
None listed