An interventional study of Repetitive Transcranial Magnetic Stimulation and Cervical Trans-spinal Magnetic Stimulation in Parkinson's Disease (PD), Gait Disorders and Transcranial Magnetic Stimulation, sponsored by Universidade Federal de Pernambuco. Recruiting at 1 site in Brazil. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Universidade Federal de Pernambuco is the lead sponsor of 166 studies on the registry; 22 are open to participants now.
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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 (MoCA) score lower than 21 points; (iv) prior surgical procedures for Parkinson's disease; or (v) to magnetic stimulation techniques, including a history of seizures or the presence of metallic implants in the neck or spinal region.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Repetitive Transcranial Magnetic Stimulation · Device: Cervical Trans-spinal Magnetic Stimulation
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.
Device: Repetitive Transcranial Magnetic Stimulation · Device: Thoracic Trans-spinal Magnetic Stimulation
Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters.
Also known as: rTMS
Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters.
Also known as: tsMS
Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters.
Also known as: tsMS
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.
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)
Plan to share: No — 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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