NCT03368703

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 19, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

December 19, 2016

Last Update Submit

January 10, 2020

Conditions

Physiology

Keywords

COPDTranscranial direct-current stimulationTranscranial magnetic stimulationMotor-evoked potentialsInhibitionMuscle weakness

Outcome Measures

Primary Outcomes (1)

  • Change in motor-evoked potentials

    Cortical excitability

    Baseline (pre-intervention) ; Post-Stim (immediately post-intervention) ; Post-30 (30min post-intervention)

Secondary Outcomes (4)

  • Change in short-interval intracortical inhibition

    Baseline (pre-intervention) ; Post-Stim (immediately post-intervention) ; Post-30 (30min post-intervention)

  • Change in cortical silent period

    Baseline (pre-intervention) ; Post-Stim (immediately post-intervention) ; Post-30 (30min post-intervention)

  • Change in cortical voluntary activation

    Baseline (pre-intervention) ; Post-Stim (immediately post-intervention) ; Post-30 (30min post-intervention)

  • Change in strength

    Baseline (pre-intervention) ; Post-Stim (immediately post-intervention) ; Post-30 (30min post-intervention)

Study Arms (2)

COPD patients

EXPERIMENTAL

COPD patients group

Device: Anodal transcranial direct-current-stimulationDevice: Sham transcranial direct-current-stimulation

Healthy subjects

ACTIVE COMPARATOR

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

Device: Anodal transcranial direct-current-stimulationDevice: Sham transcranial direct-current-stimulation

Interventions

Anodal transcranial direct-current-stimulationDEVICE

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.

COPD patientsHealthy subjects
Sham transcranial direct-current-stimulationDEVICE

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.

COPD patientsHealthy subjects

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques du Souffle

Lodève, Herault, 34700, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveInhibition, PsychologicalMuscle Weakness

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Philippe Guerin, MD

    5 Santé

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 11, 2017

Study Start

June 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)