NeurophysiologyNCT03807258
Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients
A study testing Transcranial magnetic stimulation (TMS) in people with Neurophysiology and Physiology, run by 5 Santé at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurophysiology, Physiology
- What is being tested?
- Transcranial magnetic stimulation (TMS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Oct 2018to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health insurance
- Patients : COPD Gold II-IV
Who cannot join
- Pregnant women
- Seizures
- Unable to give written consent
- Metalic object above shoulders
- Dermatological issue concerning surface electrodes
- Caffeine consumption > 4 coffee / day
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- Neurological disorders
- Opioid-based treatment
- Patients : recent exacerbation (< 4 weeks)
- Patients : rehabilitation in previous 1 year
Trial locations and contacts
2 sites in 1 country.
France2 sites
Cliniques du Souffle
Lodève, Herault, 34700
Cliniques du Souffle
Osséja, Pyrenees Orientales, 66340
About this study
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.
Read the 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.
- Conditions
- Neurophysiology, Physiology
- Being tested
- Transcranial magnetic stimulation (TMS)
- Keywords
- COPD, Transcranial magnetic stimulation, Motor-evoked potentials, Muscle weakness, Interhemispheric, Inhibition
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscle Weakness, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation (TMS)Other
Evaluations by TMS
| Study group | Role | What they receive |
|---|---|---|
| COPD patients group | Experimental | COPD patients undergoing transcranial magnetic stimulation (TMS) evaluations. Receives: Other: Transcranial magnetic stimulation (TMS) |
| Controls group | Active comparator | Healthy matched controls undergoing transcranial magnetic stimulation (TMS) evaluations. Receives: Other: Transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
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.
Measured: Baseline
Interhemispheric inhibition
Interhemispheric inhibition, from contralateral to ipsilateral motor cortex, using reference method from Ferbert et al., 1992.
Measured: Baseline
Relationship between inter hemispheric inhibition and voluntary strength
Correlation coefficient between inter hemispheric inhibition and maximal isometric force production
Measured: Baseline
S100B and GFAP
Serum concentrations of S100B and GFAP proteins, brain lesions markers
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start20 Oct 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurophysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- COPD Patients vs. Controls
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- 5 Santé
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Oliver, MD, Principal investigator, 5 Santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807258
- Sponsor's protocol ID
- 5S_PHYCOM
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients
- ClinicalTrials.gov ID
- NCT03807258
- Acronym / sponsor ID
- 5S_PHYCOM
- Conditions
- Neurophysiology, Physiology
- Keywords
- COPD, Transcranial magnetic stimulation, Motor-evoked potentials, Muscle weakness, Interhemispheric, Inhibition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- 5 SantéUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- COPD Patients vs. Controls
| Arm | Type | Receives |
|---|---|---|
| COPD patients group | Experimental | Other: Transcranial magnetic stimulation (TMS)COPD patients undergoing transcranial magnetic stimulation (TMS) evaluations. |
| Controls group | Active comparator | Other: Transcranial magnetic stimulation (TMS)Healthy matched controls undergoing transcranial magnetic stimulation (TMS) evaluations. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Health insurance
- Patients : COPD Gold II-IV
Key exclusion criteria (10 listed)
- Pregnant women
- Seizures
- Unable to give written consent
- Metalic object above shoulders
- Dermatological issue concerning surface electrodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulation (TMS)Evaluations by TMS | Other | COPD patients group, Controls group |
Primary outcome
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.
4 secondary outcomes
Ipsilateral inhibition ratio : rest - 50% mvic
Time frame: Baseline
Interhemispheric inhibition
Time frame: Baseline
Relationship between inter hemispheric inhibition and voluntary strength
Time frame: Baseline
S100B and GFAP
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Oliver, MD principal investigator
5 Santé
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation (TMS) in people with Neurophysiology and Physiology, run by 5 Santé at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral excitability ratio : rest - 50% mvic (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.