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Characterization of the Immunological Profile Patients With Post-polio Syndrome

NCT ID: NCT03396783

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2020-02-22

Brief Summary

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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.

Detailed Description

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Conditions

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Poliomyelitis Sequelae

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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SPP

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

Group Type EXPERIMENTAL

blood test

Intervention Type BIOLOGICAL

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

electromyogram and walk test

Intervention Type OTHER

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

Control

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

Group Type OTHER

blood test

Intervention Type BIOLOGICAL

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

Interventions

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blood test

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

Intervention Type BIOLOGICAL

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle LAFFONT

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

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CHRU Lapeyronie

Montpellier, Herault, France

Site Status

Countries

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France

Other Identifiers

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UF9753

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL16_0080

Identifier Type: -

Identifier Source: org_study_id