Characterization of the Immunological Profile Patients With Post-polio Syndrome

University Hospital Center (CHU)

Status: Completed

Conditions: Poliomyelitis Sequelae

Treatments: Biological: blood test; Other: electromyogram and walk test

Study type: Interventional

Funder types: Other

Identifiers

NCT03396783

RECHMPL16_0080

UF9753 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

SPP

Experimental group

Description:

during the visit, nurse will make a blood test for biological and immunological analysis, electromyogram and walk test

Treatment:

Biological: blood test

Other: electromyogram and walk test

Control

Other group

Description:

during the visit, nurse will make a blood test for biological and immunological analysis

Treatment:

Biological: blood test