Characterization of the Immunological Profile Patients With Post-polio Syndrome

Poliomyelitis Sequelae Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396783
• Other study ID #: RECHMPL16_0080
• Secondary ID: UF9753
• Status: Completed
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: February 22, 2020

Study information

• Verified date: January 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 22, 2020
• Est. primary completion date: February 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Poliomyelitis
• Poliomyelitis Sequelae
• Postpoliomyelitis Syndrome

Intervention

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

Other:
• electromyogram 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

Locations

Country	Name	City	State
France	CHRU Lapeyronie	Montpellier	Herault

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokines blood concentrations		blood sample during inclusion visit
Primary	lymphocytes blood concentrations		blood sample during inclusion visit