Characterization of the Immunological Profile Patients With Post-polio Syndrome

Not Applicable

Completed

• Conditions: Poliomyelitis Sequelae
• Interventions: Biological: blood test; Other: electromyogram and walk test

• Registration Number: NCT03396783
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-09
• Study Start: 2017-12-06
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-11
• Status Verified: 2020-01
• Primary Completion: 2020-02-22
• Study Completion: 2020-02-22
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
SPP	electromyogram and walk test	during the visit, nurse will make a blood test for biological and immunological analysis, electromyogram and walk test
SPP	blood test	during the visit, nurse will make a blood test for biological and immunological analysis, electromyogram and walk test
Control	blood test	during the visit, nurse will make a blood test for biological and immunological analysis

Primary Outcome Measures

Name	Time	Method
lymphocytes blood concentrations	blood sample during inclusion visit
cytokines blood concentrations	blood sample during inclusion visit

Trial Locations

Locations (1)

CHRU Lapeyronie; 🇫🇷 Montpellier, Herault, France