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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546529
• Other study ID #: JDLDCA
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: June 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Musculoskeletal Pain
• Parkinson Disease

Intervention

Device:
• Trans-spinal Magnetic Stimulation (TsMS)
Patients undergoing real TsMS with coil
• Sham Trans-spinal Magnetic Stimulation (TsMS)
Patients undergoing placebo TsMS with coil

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)