An interventional study of Anodal transcranial direct-current-stimulation and Sham transcranial direct-current-stimulation in Physiology, sponsored by 5 Santé. Completed at 1 site in France. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by 5 Santé · Not applicable, Interventional, and Basic science
Patients with COPD have lower cortical activation and higher cortical inhibitory levels. The purpose of this study is to test the reversibility the lower cortical activation by counterbalancing the increased cortical inhibitory levels with neuro-modulation.
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 prognostic. Even if many papers have enlightened damages at a peripheral level, the muscular atrophy itself cannot totally explain the loss in force. Furthermore, the contractile properties of COPD muscles fibres are preserved. Consequently, it seems that the peripheral muscle weakness cannot only be explained by peripheral factors and central structures may be involved.
A recent work showed that during quadriceps voluntary contraction, cortical activation in COPD patients was significantly lower than in healthy subjects, contributing in the loss in strength. However, the pathophysiology underlying this loss of strength is still unclear and two hypotheses can be advanced: 1) the influence of anatomical lesions in the brain of COPD patients and 2) the particular metabolism of this population. Indeed, COPD patients show a reduced oxidative activity and an increased glycolytic contribution (decreased type I fibres and increased type II fibres, increased glycolytic enzymes activity, increased metabolites production). This specific metabolic may lead to an over-activation of type III-IV afferents, projecting onto somatosensory cortex sensitive to metabolites at a peripheral level, and produce inhibitory activity on the primary motor cortex, seat of the motor control. What is reported in the literature so far, is that COPD patients display increased cortical inhibitory values than healthy subjects.
Therefore, beyond understanding better the nervous mechanisms involved in the COPD's peripheral muscle weakness, the aim of this study is to counterbalance this increased cortical inhibitory level.
We hypothesize that modulating inhibitory processes at a cortical level would induced a reduction of inhibitions in patients with COPD and an increase in the force produced. In case this hypothesis would be verified, we will be able to confirm that this increased cortical level in COPD patients is reversible and may be a target for rehabilitation.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 34 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →5 Santé is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD patients group
Device: Anodal transcranial direct-current-stimulation · Device: Sham transcranial direct-current-stimulation
Healthy subject group, matched with COPD patients group on age, weight and BMI
Device: Anodal transcranial direct-current-stimulation · Device: Sham transcranial direct-current-stimulation
2mA / 20min Anodal and Sham tDCS over dominant M1. Anodal tDCS consists of 30s of ramp up followed by 20min of stimulation and 30s of ramp down.
Sham tDCS consists of only 30s of ramp up followed by 30s of ramp down and no further stimulation. Participants therefore have the same feeling for both modalities : slight itching due to the induced current at the beginning of the protocol (during around 30s) allowing no differentiation by the participant between the anodal or sham sessions.
Change in motor-evoked potentials
Cortical excitability
Time frame: Baseline (pre-intervention) ; Post-Stim (immediately post-intervention) ; Post-30 (30min post-intervention)
Change in short-interval intracortical inhibition
Cortical inhibition level
Time frame: Baseline (pre-intervention) ; Post-Stim (immediately post-intervention) ; Post-30 (30min post-intervention)
Change in cortical silent period
Cortical inhibition level
Time frame: Baseline (pre-intervention) ; Post-Stim (immediately post-intervention) ; Post-30 (30min post-intervention)
Change in cortical voluntary activation
Motor command
Time frame: Baseline (pre-intervention) ; Post-Stim (immediately post-intervention) ; Post-30 (30min post-intervention)
Change in strength
Functional output
Time frame: Baseline (pre-intervention) ; Post-Stim (immediately post-intervention) ; Post-30 (30min post-intervention)
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2017 to primary completion in Jun 2018, 12 months.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 12 months is below that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
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