Physiopathology of Lower Cortical Activation in COPD Patients: Contribution of Cortical Neuromodulation

NCT ID: NCT03368703

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-06-30

Brief Summary

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.

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 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.

Conditions

Physiology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

COPD patients

COPD patients group

Group Type: EXPERIMENTAL

Anodal transcranial direct-current-stimulation

Intervention Type: DEVICE

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 transcranial direct-current-stimulation

Intervention Type: DEVICE

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.

Healthy subjects

Healthy subject group, matched with COPD patients group on age, weight and BMI

Group Type: ACTIVE_COMPARATOR

Anodal transcranial direct-current-stimulation

Intervention Type: DEVICE

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 transcranial direct-current-stimulation

Intervention Type: DEVICE

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.

Interventions

Anodal 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.

Intervention Type: DEVICE

Sham transcranial direct-current-stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Health insurance
• Patients : COPD Gold II-IV
• Patients : No rehabilitation since at least 1 yrs
• Control : sedentary (< 9 Voorips)

Exclusion Criteria

• Pregnant women
• Seizures
• Unable to give written consent
• Metalic object above shoulders
• Dermatological issue concerning surface electrodes
• Drugs influencing central nervous system
• Caffeine consumption > 4 coffee / day
• Neurological disorders
• Patients : recent exacerbation (< 4 weeks)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

5 Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Guerin, MD

Role: PRINCIPAL_INVESTIGATOR

5 Santé

Locations

Cliniques du Souffle

Lodève, Herault, France

Countries

France

Other Identifiers

5S_EXCCOM

Identifier Type: -

Identifier Source: org_study_id