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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
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Poliomyelitis Sequelae

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 9, 2017
Last Updated
December 13, 2022
Sponsor
University Hospital, Montpellier
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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

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Characterization of the Immunological Profile Patients With Post-polio Syndrome

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