Characterization of the Immunological Profile Patients With Post-polio Syndrome

Characterization of the Immunological Profile Patients With Post-polio Syndrome in Comparison With These Control Subjects

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.

Study Overview

• Status: Completed
• Conditions: Poliomyelitis Sequelae
• Intervention / Treatment: Biological: blood test; Other: electromyogram and walk test

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Herault
    • Montpellier, Herault, France, 34295
      • CHRU Lapeyronie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPP; during the visit, nurse will make a blood test for biological and immunological analysis, electromyogram and walk test	Biological: blood test; during the visit, nurse will make a blood test for biological and immunological analysis; Other: electromyogram and walk test; during the visit, measuring the amount of functional motor units at the muscular level and the distance traveled during a 2 minute walk
Other: Control; during the visit, nurse will make a blood test for biological and immunological analysis	Biological: blood test; during the visit, nurse will make a blood test for biological and immunological analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cytokines blood concentrations	blood sample during inclusion visit
lymphocytes blood concentrations	blood sample during inclusion visit

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Isabelle LAFFONT, UH Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Actual): February 22, 2020
• Study Completion (Actual): February 22, 2020

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Central Nervous System Infections; Neurodegenerative Diseases; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Muscular Disorders, Atrophic; Myelitis; Poliomyelitis; Postpoliomyelitis Syndrome
• Other Study ID Numbers: RECHMPL16_0080; UF9753 (Other Identifier: UH Montpellier)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No