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

Universidade Federal de Pernambuco

Status: Enrolling

Conditions: Transcranial Magnetic Stimulation; Gait Disorders; Spinal Cord Stimulation; Parkinson's Disease (PD)

Treatments: Device: Repetitive Transcranial Magnetic Stimulation; Device: Cervical Trans-spinal Magnetic Stimulation; Device: Thoracic Trans-spinal Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07488026

TMS_tsMS_DP

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

rTMS + Cervical tsMS

Experimental group

Description:

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.

Treatment:

Device: Cervical Trans-spinal Magnetic Stimulation

Device: Repetitive Transcranial Magnetic Stimulation

rTMS + Thoracic tsMS

Experimental group

Description:

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.

Treatment:

Device: Thoracic Trans-spinal Magnetic Stimulation

Device: Repetitive Transcranial Magnetic Stimulation