Effects of the Stimulation Site of tsMS With TMS on Functional Mobility in Individuals With Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive Transcranial Magnetic Stimulation, Cervical Trans-spinal Magnetic Stimulation, Thoracic Trans-spinal Magnetic Stimulation.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease (PD), Gait Disorders, Transcranial Magnetic Stimulation, Spinal Cord Stimulation. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of the Stimulation Site of Trans-spinal Magnetic Stimulation Combined With Transcranial Magnetic Stimulation on Functional Mobility in Individuals With Parkinson's Disease
Overview
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
- Device Repetitive Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters. - Device Cervical Trans-spinal Magnetic Stimulation
Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters. - Device Thoracic Trans-spinal Magnetic Stimulation
Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters.
Primary outcome measures
- Functional Mobility (Timed Up and Go Test) [Time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention]
Secondary outcome measures (8)
- Statatic and Dynamic Balance (Mini Balance Evaluation Systems Test - MiniBESTest) [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) [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) [Time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention]
- Gait speed (10 meter-walk test) [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) [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 [Time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention]
- Global Perceived Improvement (Global perceived change scale) [Time frame: At Day 10 (end of intervention)]
- Adverse events [Time frame: Throughout the intervention period (10 days)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Universidade Federal de Pernambuco — Recife
Identifiers
NCT: NCT07488026 · TMS_tsMS_DP