Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients

January 10, 2020 updated by: 5 Santé
Patients with COPD have lower capability of activating their muscles. At the cortical level, force production is not only controlled by contralateral primary motor cortex but also by ipsilateral motor cortex. The aim of this study is to determine whether ipsilateral areas are functionally impaired in COPD.

Study Overview

Status

Completed

Detailed Description

Chronic obstructive pulmonary disease (COPD) patients exhibit not only respiratory symptoms but also a peripheral muscular weakness. This weakness is characterized by a loss in strength, harmful for the patients' life quality and vital prognosis (Swallow et al., 2007). Even if many studies have enlightened damages at a peripheral level, the muscular atrophy itself cannot totally explain the loss in force (Menon et al., 2012). Furthermore, the contractile properties of COPD muscles fibres are preserved (Debigare et al., 2003). Consequently, peripheral muscle weakness cannot only be explained by peripheral factors and central structures must be investigated.

At the central level, it is admitted that force production is controlled by the activation of contralateral motor areas. In COPD, these areas were found to be less activated than in controls during force production (Alexandre et al., 2014). However, recent studies bring the evidence that ipsilateral motor areas are also mobilized to cope demand during such task. The activation of ipsilateral areas is possible through inter hemispheric pathways, as the corpus callosum. Recently, the integrity of the corpus callosum have been linked to the capability of activating the ipsilateral motor cortex (Chiou et al., 2014) during force production. This is of concern knowing that several studies reported white matter lesions in the brain of COPD patients (Dodd et al, 2012) and more precisely in regions containing the corpus callosum (Lahousse et al., 2013).

Therefore, we hypothesize that COPD patients have a lower capability of activating their ipsilateral motor cortex during force production compared to controls.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Herault
      • Lodeve, Herault, France, 34700
        • Cliniques du Souffle
    • Pyrenees Orientales
      • Osséja, Pyrenees Orientales, France, 66340
        • Cliniques du Souffle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health insurance
  • Patients : COPD Gold II-IV

Exclusion Criteria:

  • Pregnant women
  • Seizures
  • Unable to give written consent
  • Metalic object above shoulders
  • Dermatological issue concerning surface electrodes
  • Caffeine consumption > 4 coffee / day
  • Neurological disorders
  • Opioid-based treatment
  • Patients : recent exacerbation (< 4 weeks)
  • Patients : rehabilitation in previous 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: COPD patients group
COPD patients undergoing transcranial magnetic stimulation (TMS) evaluations.
Evaluations by TMS
ACTIVE_COMPARATOR: Controls group
Healthy matched controls undergoing transcranial magnetic stimulation (TMS) evaluations.
Evaluations by TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ipsilateral excitability ratio : rest - 50% mvic
Time Frame: Baseline
Ratio of ipsilateral excitability. Measured at rest, and during a 50% max. isometric contraction. Then, ipsilateral excitability ratio = rest / 50% * 100.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ipsilateral inhibition ratio : rest - 50% mvic
Time Frame: Baseline
Ratio of ipsilateral inhibition. Measured at rest, and during a 50% max. isometric contraction. Then, ipsilateral inhibition ratio = rest / 50% * 100. SICI (2ms) method is used to quantify inhibition.
Baseline
Interhemispheric inhibition
Time Frame: Baseline
Interhemispheric inhibition, from contralateral to ipsilateral motor cortex, using reference method from Ferbert et al., 1992.
Baseline
Relationship between inter hemispheric inhibition and voluntary strength
Time Frame: Baseline
Correlation coefficient between inter hemispheric inhibition and maximal isometric force production
Baseline
S100B and GFAP
Time Frame: Baseline
Serum concentrations of S100B and GFAP proteins, brain lesions markers
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Nicolas Oliver, MD, 5 Santé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 20, 2018

Primary Completion (ACTUAL)

March 30, 2019

Study Completion (ACTUAL)

March 30, 2019

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (ACTUAL)

January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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