Characterization of the Immunological Profile Patients With Post-polio Syndrome
Primary Purpose
Poliomyelitis Sequelae
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood test
electromyogram and walk test
Sponsored by
About this trial
This is an interventional other trial for Poliomyelitis Sequelae
Eligibility Criteria
Inclusion Criteria:
Subjects with Post-polio Syndrome :
- age ≥ 18 years
- meeting the definition of the SPP according to the criteria of Halstead et al. (1995)
Controlled subjects :
- age ≥ 18 years
- matched on sex and age (+/- 5 years) with subjects with PPS
Exclusion Criteria:
- intercurrent neurological pathology,
- uncontrolled cardiovascular risk factors
- pulmonary comorbidity
- endocrine disorders
- systemic inflammatory pathology, autoimmune disease, dry syndrome,
- renal failure
- anti-inflammatory treatment in progress or in the previous month, or immunoregulatory aim whatever its nature,
- patients with SPP who received polyvalent IV immunoglobulins in the 3 years prior to inclusion, or taking anticoagulants
Sites / Locations
- CHRU Lapeyronie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
SPP
Control
Arm Description
during the visit, nurse will make a blood test for biological and immunological analysis, electromyogram and walk test
during the visit, nurse will make a blood test for biological and immunological analysis
Outcomes
Primary Outcome Measures
cytokines blood concentrations
lymphocytes blood concentrations
Secondary Outcome Measures
Full Information
NCT ID
NCT03396783
First Posted
November 9, 2017
Last Updated
December 13, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03396783
Brief Title
Characterization of the Immunological Profile Patients With Post-polio Syndrome
Official Title
Characterization of the Immunological Profile Patients With Post-polio Syndrome in Comparison With These Control Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
February 22, 2020 (Actual)
Study Completion Date
February 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many patients with polio sequelae have persistent and progressive worsening more than 15 years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal pain. In these patients, there is a denervation process associated with insufficient reinnervation. The frequency of this syndrome post-polio (SPP) is of the order of 20 to 60% according to the studies. In the literature, several studies have advanced the hypothesis of immune dysregulation to this late degradation, with greater expression of pro-inflammatory cytokines, and abnormal phenotypic expression of T cells in the bloodstream. In this context, the use of immunomodulatory immunoglobulin IV treatment was studied several times, with no significant result on pain, fatigue and muscle strength scores. In the absence of significant efficacy of immunoglobulin treatment, the objective of this study is therefore to define the immunological profile of patients with post-polio syndrome, compared with control subjects, in order to support the pathophysiology of this syndrome. to study the possible presence of an inflammatory syndrome associated with this syndrome. On the other hand, depending on the results found, referral to targeted therapies could be considered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis Sequelae
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPP
Arm Type
Experimental
Arm Description
during the visit, nurse will make a blood test for biological and immunological analysis, electromyogram and walk test
Arm Title
Control
Arm Type
Other
Arm Description
during the visit, nurse will make a blood test for biological and immunological analysis
Intervention Type
Biological
Intervention Name(s)
blood test
Intervention Description
during the visit, nurse will make a blood test for biological and immunological analysis
Intervention Type
Other
Intervention Name(s)
electromyogram and walk test
Intervention Description
during the visit, measuring the amount of functional motor units at the muscular level and the distance traveled during a 2 minute walk
Primary Outcome Measure Information:
Title
cytokines blood concentrations
Time Frame
blood sample during inclusion visit
Title
lymphocytes blood concentrations
Time Frame
blood sample during inclusion visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with Post-polio Syndrome :
age ≥ 18 years
meeting the definition of the SPP according to the criteria of Halstead et al. (1995)
Controlled subjects :
age ≥ 18 years
matched on sex and age (+/- 5 years) with subjects with PPS
Exclusion Criteria:
intercurrent neurological pathology,
uncontrolled cardiovascular risk factors
pulmonary comorbidity
endocrine disorders
systemic inflammatory pathology, autoimmune disease, dry syndrome,
renal failure
anti-inflammatory treatment in progress or in the previous month, or immunoregulatory aim whatever its nature,
patients with SPP who received polyvalent IV immunoglobulins in the 3 years prior to inclusion, or taking anticoagulants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle LAFFONT
Organizational Affiliation
UH Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Lapeyronie
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Learn more about this trial
Characterization of the Immunological Profile Patients With Post-polio Syndrome
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