Multiple Sclerosis Clinical Trial
Official title:
Evaluation of Cerebrovascular Hemodynamics With Transcranial Doppler and Near-infrared Spectroscopy in Patients With Multiple Sclerosis
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.
MS is a poorly understood chronic disease of the central nervous system characterized by
focal inflammatory demyelinating lesions and diffuse axonal degeneration. Recent magnetic
resonance imaging (MRI) studies demonstrated a widespread decrease in cerebral perfusion -
expressed as cerebral blood flow (CBF) - throughout the normal-appearing white matter of
patients with MS, which seems not just to be secondary to axonal degeneration with reduced
metabolic demands, but in contrast may actively contribute to MS pathology.
Reduced CBF in MS is mediated by elevated levels of the potent vasoconstrictive agent
endothelin-1 (ET-1), likely released in the cerebral circulation by reactive astrocytes, and
can reversed with administration of the ET-1 antagonist bosentan.
Phase-contrast MRI recently demonstrated reduced cervical arterial blood flow velocities to
the brain in patients MS as compared to control subjects. The aim of this study is to
investigate the potential of TCD and NIRS, more simple and non-invasive bedside method, to
evaluate changes in the cerebral circulation between patients with MS and control subjects.
A baseline TCD examination will be performed in each subject (MS patients and controls) over
the temporal bone window on both sides. Middle cerebral artery wave forms will be identified
at a depth range of 40-60 mm and a stable forward waveform with good intensity will be
selected. TCD probes (2 MHz) will be mounted by a head frame to ensure a constant angle of
insonation throughout the procedure. Mean, peak-systolic and end-diastolic blood flow
velocities can be directly recorded from the machine. Blood pressure (BP) and heart rate
will be measured with a finger plethysmograph. The cuff will be applied to the middle finger
of the left hand, first placed at the heart level to calibrate the system, afterwards the
hand is placed next to the subject in rest. Near-infrared spectroscopy will be performed to
measure cerebral frontal lobe oxygen saturation. NIRS is performed with two large sensors,
attached on patient's forehead bilaterally. In bright environments, a light-blocker to cover
the sensors will be used to reduce interference from ambient light. Continuously NIRS
recording with a 2s interval refreshment. Measurements will be done in upright and supine
positions. The expected duration of the entire TCD protocol is 30 minutes.
The TCD examination will be repeated only in the patients with MS (i.e. not in control
subjects) 4 h after the oral intake of 62.5 mg bosentan (Tracleer®) (when peak plasma
concentrations are expected). This is a purely academic study and Bosentan will be purchased
through the hospital pharmacy. The most common side effect of daily treatment with bosentan
is hepatotoxicity. Adverse reactions to one single dose are very unlikely. The primary aim
is to investigate the potential of TCD to evaluate changes in the cerebral circulation
between patients with MS and controls. Bosentan is not the object of investigation in this
study but can be considered as a 'Non Investigational Medicinal Product' (N.I.M.P.).
Patients with MS will receive the product to increase CBF, an effect which has already been
demonstrated in an earlier perfusion-weighted MRI study.
Fifteen patients with relapsing-remitting or progressive MS and 15 healthy controls, matched
for sex and age, will be included in this study. Sample size calculation is based on the
number of inclusion in previous studies regarding cerebral hemodynamic parameters in MS
(mostly between 10 and 30).
The statistical analyses will be conducted with Statistical Package for the Social Sciences
(SPSS) software. Mann Whitney U or Wilcoxon signed rank tests will be used where
appropriate.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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