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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Musculoskeletal Pain, Parkinson Disease

Intervention / Treatment
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* Device: Trans-spinal Magnetic Stimulation (TsMS)
* Device: Sham Trans-spinal Magnetic Stimulation (TsMS)


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TsMS active<br>Patients undergoing real Trans-spinal Magnetic Stimulation (TsMS) for 8 weeks | Device: Trans-spinal Magnetic Stimulation (TsMS)<br>* Patients undergoing real TsMS with coil<br>|
| Sham Comparator: TsMS sham<br>Patients undergoing placebo Trans-spinal Magnetic Stimulation (TsMS) for 8 weeks | Device: Sham Trans-spinal Magnetic Stimulation (TsMS)<br>* Patients undergoing placebo TsMS with coil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of responders | 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. | base line (moment of inclusion) and the last day of the patient assessment (2x in two months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline of Pain | 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) | 
| Incidence of Treatment-Emergent Adverse Events | 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 | Immediately after the intervention (session of stimulation) | 
| Mood | Assess mood by hospital anxiety and depression scale | base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months) | 
| Quality of life related to pain relief | Assess by EuroQol- 5 Dimension | base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months) | 
| Parkinson's disease motor symptoms | Assess by UPDRS part III | base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months) | 
| Interference in daily activities | measured by brief pain inventory | base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months) | 
| Global impression of change | Assess % of very much and much improved | base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-motor symptom, Musculoskeletal Pain, Parkinson disease, treatment, Trans-spinal Magnetic Stimulation