Trans-spinal Magnetic Stimulation (TsMS) in Parkinson's Disease- Related Musculoskeletal Pain

Parkinson disease is the second most common neurodegenerative disease. Pain is the frequent non-motor symptom that significantly compromises the quality of life, affecting 80% of patients during the course of the disease. There is currently no evidence-based treatment for PD-related pain in general. Nociceptive pain is the most frequent pain in PD an is frequently musculoskeletal in nature. Epidural spinal cord stimulation is known to provide analgesic effects in several types of pain syndromes. Here we test analgesic effects of a non-invasive trans-spinal magnetic stimulation as an add-on treatment for nociceptive (musculoskeletal) pain directly related to Parkinson disease.

Background: pain is frequent non-motor symptom in Parkinson's disease (PD) that significantly compromises the quality of life, affecting 80% of patients during the course of the disease. Nociceptive pain is the most frequent subtype, mainly musculoskeletal in nature. There is currently no evidence-based treatment for PD-related pain in general. The present study tests the effectiveness and safety of non-invasive trans-spinal magnetic stimulation (TsMS) to treat musculoskeletal pain directly related to PD in a sham-controlled randomized approach. Patients and Methods: this is a randomized, sham-controlled trial including 40 subjects, aged between 18 and 85 years, with musculoskeletal pain directly related to PD, that will be randomized to receive TsMS active or TsMS sham in a 1:1 ratio. Enrollment will take place at the Pain Center of the University of São Paulo and Movement Disorders Center of the University of São Paulo. We have decided to perform an interim analysis when 24 patients will be included in the trial in order to assess safety and calculate effect size of the active intervention, after meeting with the research and statistical board. A decision will thereafter be made to, either: 1: halt the study due to futility, 2: continue the study with a new target sample size based on the calculations made with the effect from the n= 24 sample. Expected results: the study hypothesis is that non-invasive trans-spinal magnetic stimulation is superior to sham and it is safe to use that device in patients with nociceptive (musculoskeletal) pain in PD.

non-motor symptom, Musculoskeletal Pain, Parkinson disease, treatment, Trans-spinal Magnetic Stimulation

Number of individuals presenting 50% pain intensity reduction (on VNS 0-10 average pain of BPI item 5) in the active vs the sham group at the last (8th week) assessment compared to baseline values.

Assessing by score derivated of Parkinson's Disease Pain Classification System (PD-PCS). This score range from 0 (minimum) to 90 (maximum), being considered an effective improvement in the patient's pain when the pain decreases at least in 50% from the basal score.

base line (moment of inclusion) and in the last day after the final session of TMS-e (2x in two months)

The safety of trans-spinal magnetic stimulation (TsMS) will be assessed by measuring the number of participants who experience serious events. Each serious adverse event be described in detail

Inclusion Criteria: Parkinson disease Parkinsson disease related musculoskeletal Pain Signed term of informed consent Exclusion Criteria: Pregnant or lacting women Predominant neuropathic pain The presence of psychiatric disorders such as uncontrolled posttraumatic stress disorder, uncontrolled depression, uncontrolled anxiety disorder and suicidal ideation; Who wishes at any time to abandon the study;

The complete IPD will be shared with other authors who wish to use it in individual patient data (IPD) meta-analysis. Other specific situations will be discussed on a case-by-case basis.

The IPD will be available after the estimated study completion time (December/2021) and for five years.

use in individual patient data (IPD) meta-analysis. Other specific situations will be discussed on a case-by-case basis.