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

NCT ID: NCT04546529

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2021-06-04

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.

Conditions

Musculoskeletal Pain; Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TsMS active

Patients undergoing real Trans-spinal Magnetic Stimulation (TsMS) for 8 weeks

Group Type: ACTIVE_COMPARATOR

Trans-spinal Magnetic Stimulation (TsMS)

Intervention Type: DEVICE

Patients undergoing real TsMS with coil

TsMS sham

Patients undergoing placebo Trans-spinal Magnetic Stimulation (TsMS) for 8 weeks

Group Type: SHAM_COMPARATOR

Sham Trans-spinal Magnetic Stimulation (TsMS)

Intervention Type: DEVICE

Patients undergoing placebo TsMS with coil

Interventions

Trans-spinal Magnetic Stimulation (TsMS)

Patients undergoing real TsMS with coil

Intervention Type: DEVICE

Sham Trans-spinal Magnetic Stimulation (TsMS)

Patients undergoing placebo TsMS with coil

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Daniel Ciampi Araujo de Andrade, MD, PhD

MD, PhD (Head of Pain Division)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Ciampi, PHD

Role: STUDY_CHAIR

University of São Paulo

Locations

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

São Paulo, , Brazil

Countries

Brazil

References

Lapa JDDS, da Cunha PHM, Teixeira MJ, Brito Medeiros VM, Fernandes AM, Silva de Morais AD, Graven-Nielsen T, Cury RG, Ciampi de Andrade D. Burst Transspinal Magnetic Stimulation Alleviates Nociceptive Pain in Parkinson Disease-A Pilot Phase II Double-Blind, Randomized Study. Neuromodulation. 2023 Jun;26(4):840-849. doi: 10.1016/j.neurom.2022.10.043. Epub 2022 Nov 18.

Reference Type: DERIVED

PMID: 36411151 (View on PubMed)

Other Identifiers

JDLDCA

Identifier Type: -

Identifier Source: org_study_id