Effects of the Stimulation Site of tsMS With TMS on Functional Mobility in Individuals With Parkinson's Disease
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2025
CompletedStudy Start
First participant enrolled
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 23, 2026
March 1, 2026
10 months
December 16, 2025
March 18, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention
Secondary Outcomes (8)
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
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
- +3 more secondary outcomes
Study Arms (2)
rTMS + Cervical tsMS
EXPERIMENTALParticipants 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.
rTMS + Thoracic tsMS
EXPERIMENTALParticipants 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.
Interventions
Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters.
Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters.
Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters.
Eligibility Criteria
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kátia Monte-Silva, PhD in Neurosciences
Universidade Federal de Pernambuco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 16, 2025
First Posted
March 23, 2026
Study Start
January 5, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared due to privacy and ethical considerations, as well as restrictions imposed by the ethics committee.