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NCT Number: NCT07488026

Effects of the Stimulation Site of tsMS With TMS on Functional Mobility in Individuals With Parkinson's Disease

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Location status: Recruiting

Location contact

Ana Cecília Ribeiro

CONTACT

[email protected]

+55 8199893-6664

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters.

Other names: rTMS

Cervical Trans-spinal Magnetic Stimulation

Device

Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters.

Other names: tsMS

Thoracic Trans-spinal Magnetic Stimulation

Device

Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters.

Other names: tsMS

Primary outcomes

  1. Functional Mobility (Timed Up and Go Test)

    Time frame: 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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. Gait speed (10 meter-walk test)

    Time frame: 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).

  5. 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

    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.

  6. 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

    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.

  7. Global Perceived Improvement (Global perceived change scale)

    Time frame: 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."

  8. Adverse events

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Cecília Ribeiro Nascimento, Msc. student

CONTACT

[email protected]

(81) 99893-6664 ext. +55

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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