Effects of the Stimulation Site of Trans-spinal Magnetic Stimulation Combined With Transcranial Magnetic Stimulation on Functional Mobility in Individuals With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Functional Mobility (Timed Up and Go Test)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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.
结局指标
主要结局
Functional Mobility (Timed Up and Go Test)
时间窗: 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.
次要结局
- 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)
- 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)
- Adverse events(Throughout the intervention period (10 days))
- Freezing of gait (Freezing of gait Questionnaire - FOG-Q)(Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention)
- Gait speed (10 meter-walk test)(Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention)
- Lower limb stength (Five times sit-to-stand test)(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(Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention)
- Global Perceived Improvement (Global perceived change scale)(At Day 10 (end of intervention))
研究者
Kátia Monte-Silva
Professor
Universidade Federal de Pernambuco