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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03807258
Other study ID # 5S_PHYCOM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2018
Est. completion date March 30, 2019

Study information

Verified date January 2020
Source 5 Santé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date March 30, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Transcranial magnetic stimulation (TMS)
Evaluations by TMS

Locations

Country Name City State
France Cliniques du Souffle Lodeve Herault
France Cliniques du Souffle Osséja Pyrenees Orientales

Sponsors (1)

Lead Sponsor Collaborator
5 Santé

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ipsilateral excitability ratio : rest - 50% mvic Ratio of ipsilateral excitability. Measured at rest, and during a 50% max. isometric contraction. Then, ipsilateral excitability ratio = rest / 50% * 100. Baseline
Secondary Ipsilateral inhibition ratio : rest - 50% mvic 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
Secondary Interhemispheric inhibition Interhemispheric inhibition, from contralateral to ipsilateral motor cortex, using reference method from Ferbert et al., 1992. Baseline
Secondary Relationship between inter hemispheric inhibition and voluntary strength Correlation coefficient between inter hemispheric inhibition and maximal isometric force production Baseline
Secondary S100B and GFAP Serum concentrations of S100B and GFAP proteins, brain lesions markers Baseline
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