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Clinical Trial NCT07488026 for Parkinson's Disease (PD), Gait Disorders, Transcranial Magnetic Stimulation, Spinal Cord Stimulation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effects of the Stimulation Site of tsMS With TMS on Functional Mobility in Individuals With Parkinson's Disease 30 Randomized
Clinical Trial NCT07488026 is an interventional study for Parkinson's Disease (PD), Gait Disorders, Transcranial Magnetic Stimulation, Spinal Cord Stimulation that is recruiting. It started on 5 January 2026 with plans to enroll 30 participants. Led by Universidade Federal de Pernambuco, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
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 + thorac...Show More
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
Conditions
Parkinson's Disease (PD)Gait DisordersTranscranial Magnetic StimulationSpinal Cord StimulationOther Study IDs
- TMS_tsMS_DP
NCT ID Number
Start Date (Actual)
2026-01-05
Last Update Posted
2026-03-23
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
gait disorders
spinal cord stimulation
transcranial magnetic stimulation
parkinson's disease
spinal cord stimulation
transcranial magnetic stimulation
parkinson's disease
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalrTMS + 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. | Repetitive Transcranial Magnetic Stimulation Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters. Cervical Trans-spinal Magnetic Stimulation Trans-spinal magnetic stimulation applied at the cervical level using standardized stimulation parameters. |
ExperimentalrTMS + 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. | Repetitive Transcranial Magnetic Stimulation Repetitive transcranial magnetic stimulation applied over the primary motor cortex using standardized stimulation parameters. Thoracic Trans-spinal Magnetic Stimulation Trans-spinal magnetic stimulation applied at the thoracic level using standardized stimulation parameters. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | 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). | 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. | 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. | 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." | 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). | Throughout the intervention period (10 days) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
40 Years
Eligible Sexes
All
(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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(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.
Universidade Federal de PernambucoStudy Responsible Party
Kátia Monte-Silva, Principal Investigator, Professor, Universidade Federal de Pernambuco
Study Central Contact
Contact: Ana Cecília Ribeiro Nascimento, Msc. student, (81) 99893-6664, [email protected]
1 Study Locations in 1 Countries
Pernambuco
Universidade Federal de Pernambuco, Recife, Pernambuco, Brazil
Ana Cecília Ribeiro, Contact, +55 8199893-6664, [email protected]
Recruiting