NCT03807258

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

January 15, 2019

Last Update Submit

January 10, 2020

Conditions

NeurophysiologyPhysiology

Keywords

COPDTranscranial magnetic stimulationMotor-evoked potentialsMuscle weaknessInterhemisphericInhibition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Ipsilateral inhibition ratio : rest - 50% mvic

    Baseline

  • Interhemispheric inhibition

    Baseline

  • Relationship between inter hemispheric inhibition and voluntary strength

    Baseline

  • S100B and GFAP

    Baseline

Study Arms (2)

COPD patients group

EXPERIMENTAL

COPD patients undergoing transcranial magnetic stimulation (TMS) evaluations.

Other: Transcranial magnetic stimulation (TMS)

Controls group

ACTIVE COMPARATOR

Healthy matched controls undergoing transcranial magnetic stimulation (TMS) evaluations.

Other: Transcranial magnetic stimulation (TMS)

Interventions

Transcranial magnetic stimulation (TMS)OTHER

Evaluations by TMS

COPD patients groupControls group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health insurance
  • Patients : COPD Gold II-IV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cliniques du Souffle

Lodève, Herault, 34700, France

Location

Cliniques du Souffle

Osséja, Pyrenees Orientales, 66340, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMuscle WeaknessInhibition, Psychological

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Nicolas Oliver, MD

    5 Santé

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: COPD Patients vs. Controls
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 16, 2019

Study Start

October 20, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)