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Completed

NCT Number: NCT04546529

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.

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Key information

Conditions

Musculoskeletal Pain Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pain Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Trans-spinal Magnetic Stimulation (TsMS)

Device

Patients undergoing real TsMS with coil

Sham Trans-spinal Magnetic Stimulation (TsMS)

Device

Patients undergoing placebo TsMS with coil

Primary outcomes

  1. Number of responders

    Time frame: base line (moment of inclusion) and the last day of the patient assessment (2x in two months)

    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.

Secondary outcomes

  1. Change in baseline of Pain

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

    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.

  2. Incidence of Treatment-Emergent Adverse Events

    Time frame: Immediately after the intervention (session of stimulation)

    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

  3. Mood

    Time frame: base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months)

    Assess mood by hospital anxiety and depression scale

  4. Quality of life related to pain relief

    Time frame: base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months)

    Assess by EuroQol- 5 Dimension

  5. Parkinson's disease motor symptoms

    Time frame: base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months)

    Assess by UPDRS part III

  6. Interference in daily activities

    Time frame: base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months)

    measured by brief pain inventory

  7. Global impression of change

    Time frame: base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months)

    Assess % of very much and much improved

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2020
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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