NCT02389426

Brief Summary

The aim of this study is to investigate the potential of Transcranial doppler (TCD) and Near-Infrared Spectroscopy (NIRS), more simple and non-invasive bedside methods than magnetic resonance imaging (MRI), to evaluate changes in the cerebral circulation between patients with MS and control subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable multiple-sclerosis

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

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 17, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

February 9, 2015

Last Update Submit

April 16, 2015

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisCerebral hemodynamicsCerebral hypoperfusionCerebral circulation

Outcome Measures

Primary Outcomes (1)

  • Detection of hemodynamic differences between MS patients and Healthy controls with TCD baseline.

    Evaluation of cerebral circulation parameters altogether with measured blood pressure and heart rate values.

    a 10 minute recording with TCD baseline

Secondary Outcomes (3)

  • Hemodynamic changes in MS patients detected with TCD after administration of Bosentan

    baseline and 4 hours after administration of bosentan a 10 minute recording with TCD

  • Detection of frontal lobe oxygen saturation differences between patients with multiple sclerosis and healthy controls with near-infrared spectroscopy.

    a 10 minute recording with NIRS baseline

  • Frontal lobe oxygen saturation changes in MS patients detected with NIRS after administration of Bosentan

    baseline and 4 hours after administration of bosentan a 10 minute recording with NIRS

Study Arms (2)

Patients with Multiple Sclerosis

EXPERIMENTAL

One examination with TCD baseline and with NIRS baseline, and a second examination with TCD after bosentan administration and with NIRS after bosentan administration will be performed; The examination will be repeated only in the patients with MS (i.e. not in control subjects) 4 h after the oral intake of one tablet 62.5 mg bosentan (Tracleer®) (when peak plasma concentrations are expected).

Device: TCD baselineDevice: TCD after bosentan administrationDevice: NIRS baselineDevice: NIRS after bosentan administration

Healthy controls

EXPERIMENTAL

Only one examination with TCD baseline and NIRS baseline will be performed, without administration of bosentan.

Device: TCD baselineDevice: NIRS baseline

Interventions

TCD baselineDEVICE

Measurement of cerebral circulation parameters with transcranial doppler baseline. This examination will be performed in patients with multiple sclerosis and in healthy controls.

Also known as: Transcranial doppler
Healthy controlsPatients with Multiple Sclerosis
TCD after bosentan administrationDEVICE

Measurement of cerebral circulation parameters with transcranial doppler after administration of one tablet tracleer (Bosentan) 62,5 mg per oral. This examination will only be performed in patients with multiple sclerosis.

Also known as: Transcranial doppler, Tracleer, Endothelin-1 receptor antagonist
Patients with Multiple Sclerosis
NIRS baselineDEVICE

Measurement of frontal lobe oxygen saturation with near-infrared spectroscopy baseline. This examination will be performed in patients with multiple sclerosis and in healthy controls.

Also known as: Near-infrared spectroscopy, ForeSight
Healthy controlsPatients with Multiple Sclerosis
NIRS after bosentan administrationDEVICE

Measurement of frontal lobe oxygen saturation with near-infrared spectroscopy after administration of one tablet tracleer (Bosentan) 62,5 mg per oral. This examination will only be performed in patients with multiple sclerosis.

Also known as: Near-infrared Spectroscopy, Endothelin-1 receptor antagonist, Tracleer
Patients with Multiple Sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with the diagnosis of relapsing-remitting, primary progressive of secondary progressive MS, according to the 2010 revised McDonald criteria.
  • Written informed consent must be obtained.

You may not qualify if:

  • MS patients with a known contra-indication for bosentan: liver dysfunction, use of cyclosporine A, allergy.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Universitair Ziekenhuis (UZ) Brussel. Center for Neurosciences, Vrije Universiteit Brussel

Jette, Vlaams-Brabant, 1090, Belgium

Location

Related Publications (7)

  • Law M, Saindane AM, Ge Y, Babb JS, Johnson G, Mannon LJ, Herbert J, Grossman RI. Microvascular abnormality in relapsing-remitting multiple sclerosis: perfusion MR imaging findings in normal-appearing white matter. Radiology. 2004 Jun;231(3):645-52. doi: 10.1148/radiol.2313030996.

    PMID: 15163806BACKGROUND

  • Adhya S, Johnson G, Herbert J, Jaggi H, Babb JS, Grossman RI, Inglese M. Pattern of hemodynamic impairment in multiple sclerosis: dynamic susceptibility contrast perfusion MR imaging at 3.0 T. Neuroimage. 2006 Dec;33(4):1029-35. doi: 10.1016/j.neuroimage.2006.08.008. Epub 2006 Sep 22.

    PMID: 16996280BACKGROUND

  • Varga AW, Johnson G, Babb JS, Herbert J, Grossman RI, Inglese M. White matter hemodynamic abnormalities precede sub-cortical gray matter changes in multiple sclerosis. J Neurol Sci. 2009 Jul 15;282(1-2):28-33. doi: 10.1016/j.jns.2008.12.036. Epub 2009 Jan 31.

    PMID: 19181347BACKGROUND

  • Saindane AM, Law M, Ge Y, Johnson G, Babb JS, Grossman RI. Correlation of diffusion tensor and dynamic perfusion MR imaging metrics in normal-appearing corpus callosum: support for primary hypoperfusion in multiple sclerosis. AJNR Am J Neuroradiol. 2007 Apr;28(4):767-72.

    PMID: 17416836BACKGROUND

  • D'haeseleer M, Beelen R, Fierens Y, Cambron M, Vanbinst AM, Verborgh C, Demey J, De Keyser J. Cerebral hypoperfusion in multiple sclerosis is reversible and mediated by endothelin-1. Proc Natl Acad Sci U S A. 2013 Apr 2;110(14):5654-8. doi: 10.1073/pnas.1222560110. Epub 2013 Mar 18.

    PMID: 23509249BACKGROUND

  • Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.

    PMID: 18970977BACKGROUND

  • ElSankari S, Baledent O, van Pesch V, Sindic C, de Broqueville Q, Duprez T. Concomitant analysis of arterial, venous, and CSF flows using phase-contrast MRI: a quantitative comparison between MS patients and healthy controls. J Cereb Blood Flow Metab. 2013 Sep;33(9):1314-21. doi: 10.1038/jcbfm.2013.95. Epub 2013 Jun 19.

    PMID: 23778162BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Ultrasonography, Doppler, TranscranialSpectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Ilse AS Peeters, Student

    Department of Neurology, Universitair Ziekenhuis (UZ) Brussel, Brussels. Belgium Center for Neurosciences, Vrije Universiteit Brussel, Brussels, Belgium

    PRINCIPAL INVESTIGATOR

  • Miguel D'haeseleer, MD, PhD

    Department of Neurology, Universitair Ziekenhuis (UZ) Brussel, Brussels. Belgium Center for Neurosciences, Vrije Universiteit Brussel, Brussels, Belgium

    STUDY CHAIR

  • Jacques De Keyser, MD, PhD

    Department of Neurology, Universitair Ziekenhuis (UZ) Brussel, Brussels. Belgium Center for Neurosciences, Vrije Universiteit Brussel, Brussels, Belgium

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

March 17, 2015

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

April 17, 2015

Record last verified: 2015-02

Locations

BE(1)