Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04546529
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase N/A
Start date October 5, 2020
Completion date June 4, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Not yet recruiting NCT05005208 - SocIal ROBOTics for Active and Healthy Ageing N/A
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Recruiting NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A