Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04546529
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2020-07-05
Brief Title:
Trans-spinal Magnetic Stimulation TsMS in Parkinsons Disease- Related Musculoskeletal Pain
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Trans-spinal Magnetic Stimulation TsMS in Parkinsons Disease- Related Musculoskeletal Pain
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None