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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03396783
Enrollment
73
Registered
2018-01-11
Start date
2017-12-06
Completion date
2020-02-22
Last updated
2022-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poliomyelitis Sequelae

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.

Interventions

BIOLOGICALblood test

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

OTHERelectromyogram 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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
cytokines blood concentrationsblood sample during inclusion visit
lymphocytes blood concentrationsblood sample during inclusion visit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026