Clinical trial NCT04546529: Trans-spinal Magnetic Stimulation (TsMS) in Parkinson's Disease- Related Musculoskeletal Pain
Official title: Trans-spinal Magnetic Stimulation (TsMS) in Parkinson's Disease- Related Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Parkinson Disease
Keywords: non-motor symptom
Musculoskeletal Pain
Parkinson disease
treatment
Trans-spinal Magnetic Stimulation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Number of responders
timeFrame: base line (moment of inclusion) and the last day of the patient assessment (2x in two months)
Secondary outcomes:
measure: Change in baseline of Pain
timeFrame: base line (moment of inclusion) and in the last day after the final session of TMS-e (2x in two months)
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Immediately after the intervention (session of stimulation)
measure: Mood
timeFrame: base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months)
measure: Quality of life related to pain relief
timeFrame: base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months)
measure: Parkinson's disease motor symptoms
timeFrame: base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months)
measure: Interference in daily activities
timeFrame: base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months)
measure: Global impression of change
timeFrame: base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of São Paulo
name: Daniel Ciampi, PHD
role: STUDY_CHAIR
References: