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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Parkinson Disease
• Intervention / Treatment: Device: Trans-spinal Magnetic Stimulation (TsMS); Device: Sham Trans-spinal Magnetic Stimulation (TsMS)

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-900
    • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Daniel Ciampi, PHD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: July 5, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: treatment; Parkinson disease; Musculoskeletal Pain; non-motor symptom; Trans-spinal Magnetic Stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Musculoskeletal Pain
• Other Study ID Numbers: JDLDCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The IPD will be available after the estimated study completion time (December/2021) and for five years.
• IPD Sharing Access Criteria: use in individual patient data (IPD) meta-analysis. Other specific situations will be discussed on a case-by-case basis.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No