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CompletedNCT03396783Updated Dec 14, 2022

Characterization of the Immunological Profile Patients With Post-polio Syndrome

An interventional study of blood test and electromyogram and walk test in Poliomyelitis Sequelae, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Poliomyelitis Sequelae
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    SPP

    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

  • Other
    Control

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

    Biological: blood test

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

05

What researchers measure

Primary outcomes

  1. cytokines blood concentrations

    Time frame: blood sample during inclusion visit

  2. lymphocytes blood concentrations

    Time frame: blood sample during inclusion visit

06

Study locations

1 site
  • CHRU Lapeyronie
    Montpellier, Herault 34295, France
07

Registry details

Key details

Study ID
NCT03396783
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Jan 11, 2018
Start date
Dec 6, 2017
Primary completion
Feb 22, 2020
Completion
Feb 22, 2020
Last update
Dec 14, 2022

Study contacts

Isabelle LAFFONT
principal investigator · UH Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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