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

March 18, 2026 updated by: Kátia Monte-Silva, Universidade Federal de Pernambuco

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Recruiting
        • Universidade Federal de Pernambuco
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

-

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS + Cervical tsMS
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
Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters.
Other Names:
  • rTMS
Device: Cervical Trans-spinal Magnetic Stimulation
Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters.
Other Names:
  • tsMS
Experimental: rTMS + Thoracic tsMS
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
Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters.
Other Names:
  • rTMS
Device: Thoracic Trans-spinal Magnetic Stimulation
Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters.
Other Names:
  • tsMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, at Day 10 (end of intervention), and at 15 and 30 days post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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).
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
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.
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
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.
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)
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."
At Day 10 (end of intervention)
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).
Throughout the intervention period (10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Investigators

  • Study Director: Kátia Monte-Silva, PhD in Neurosciences, Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMS_tsMS_DP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy and ethical considerations, as well as restrictions imposed by the ethics committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Transcranial Magnetic Stimulation

Clinical Trials on Repetitive Transcranial Magnetic Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe