Skip to main content
OpenTrials
Completed

NCT Number: NCT03396783

Characterization of the Immunological Profile Patients With Post-polio Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Lapeyronie

Montpellier, Herault, 34295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood test

Biological

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

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

Primary outcomes

  1. cytokines blood concentrations

    Time frame: blood sample during inclusion visit

  2. lymphocytes blood concentrations

    Time frame: blood sample during inclusion visit

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Characterization of the Immunological Profile Patients With Post-polio Syndrome in Comparison With These Control Subjects

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2018
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.