Characterization of the Immunological Profile Patients With Post-polio Syndrome

NCT03396783 | Completed

• 2 other identifiers: RECHMPL16_0080UF9753
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Poliomyelitis Sequelae

Outcome Measures

Primary Outcomes (2)

• cytokines blood concentrations

  blood sample during inclusion visit

• lymphocytes blood concentrations

  blood sample during inclusion visit

Study Arms (2)

SPP

EXPERIMENTAL

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

Biological: blood test; Other: electromyogram and walk test

Control

OTHER

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

Biological: blood test

Interventions

blood test BIOLOGICAL

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

Control; SPP

electromyogram and walk test OTHER

during the visit, measuring the amount of functional motor units at the muscular level and the distance traveled during a 2 minute walk

SPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHRU Lapeyronie

Montpellier, Herault, 34295, France

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Isabelle LAFFONT

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: January 11, 2018
• Study Start: December 6, 2017
• Primary Completion: February 22, 2020
• Study Completion: February 22, 2020
• Last Updated: December 14, 2022

Record last verified: 2020-01

Locations

FR (1)