Parkinson's Disease (PD)NCT07488026
Effects of the Stimulation Site of tsMS With TMS on Functional Mobility in Individuals With Parkinson's Disease
A study testing Repetitive Transcranial Magnetic Stimulation, Cervical Trans-spinal Magnetic Stimulation and Thoracic Trans-spinal Magnetic Stimulation in people with Parkinson's Disease (PD) and Gait Disorders, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease (PD), Gait Disorders, Transcranial Magnetic Stimulation
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation, Cervical Trans-spinal Magnetic Stimulation and Thoracic Trans-spinal Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ana Cecília Ribeiro Nascimento, Msc. student contact
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Pernambuco
Recife, Pernambuco
Ana Cecília Ribeiro, +55 8199893-6664, anaceciliaribeiro.n@gmail.com
About this study
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
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.
- Conditions
- Parkinson's Disease (PD), Gait Disorders, Transcranial Magnetic Stimulation, Spinal Cord Stimulation
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Cervical Trans-spinal Magnetic Stimulation, Thoracic Trans-spinal Magnetic Stimulation
- Keywords
- gait disorders, spinal cord stimulation, transcranial magnetic stimulation, parkinson's disease
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called rTMS
Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters.
Cervical Trans-spinal Magnetic StimulationDevice
Also called tsMS
Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters.
Thoracic Trans-spinal Magnetic StimulationDevice
Also called tsMS
Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters.
| Study group | Role | What they receive |
|---|---|---|
| rTMS + Cervical tsMS | Experimental | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Device: Cervical Trans-spinal Magnetic Stimulation |
| rTMS + Thoracic tsMS | Experimental | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Device: Thoracic Trans-spinal Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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).
Measured: Throughout the intervention period (10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start5 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Kátia Monte-Silva, PhD in Neurosciences, Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488026
- Sponsor's protocol ID
- TMS_tsMS_DP
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and ethical considerations, as well as restrictions imposed by the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07488026
- Acronym / sponsor ID
- TMS_tsMS_DP
- Conditions
- Parkinson's Disease (PD), Gait Disorders, Transcranial Magnetic Stimulation, Spinal Cord Stimulation
- Keywords
- gait disorders, spinal cord stimulation, transcranial magnetic stimulation, parkinson's disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS + Cervical tsMS | Experimental | Device: Repetitive Transcranial Magnetic Stimulation, Device: Cervical Trans-spinal Magnetic StimulationParticipants 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 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation, Device: Thoracic Trans-spinal Magnetic StimulationParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: rTMSRepetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters. | Device | rTMS + Cervical tsMS, rTMS + Thoracic tsMS |
| Cervical Trans-spinal Magnetic StimulationAlso: tsMSTrans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters. | Device | rTMS + Cervical tsMS |
| Thoracic Trans-spinal Magnetic StimulationAlso: tsMSTrans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters. | Device | rTMS + Thoracic tsMS |
Primary outcome
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.
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Cecília Ribeiro Nascimento, Msc. student contact
Kátia Monte-Silva, PhD in Neurosciences study director
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation, Cervical Trans-spinal Magnetic Stimulation and Thoracic Trans-spinal Magnetic Stimulation in people with Parkinson's Disease (PD) and Gait Disorders, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Cecília Ribeiro Nascimento, Msc. student ((81) 99893-6664 ext. +55, anaceciliaribeiro.n@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Mobility (Timed Up and Go Test) (time frame: Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.