- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03807258
Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Herault
-
Lodeve, Herault, France, 34700
- Cliniques du Souffle
-
-
Pyrenees Orientales
-
Osséja, Pyrenees Orientales, France, 66340
- Cliniques du Souffle
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Nicolas Oliver, MD, 5 Santé
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5S_PHYCOM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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