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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversidade Federal de Pernambuco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation

    Device

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

  • Cervical Trans-spinal Magnetic Stimulation

    Device

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

  • Thoracic Trans-spinal Magnetic Stimulation

    Device

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: rTMS + Cervical tsMSExperimental treatment 2 interventions
Group B: rTMS + Thoracic tsMSExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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