Use of Cannabinoids in Patients With Multiple Sclerosis
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This is a 10-week, randomised, double blind, placebo-controlled, crossover trial to
investigate the effect of Cannabis Based Medicine Extract (Sativex) on patterns of brain
activation associated with movement in 20 MS patients suffering from lower limb spasticity.
Spasticity is a common symptom in Multiple Sclerosis (MS), occurring all over the course of
the disease, particularly in the progressive phase.Physiologically, spasticity and
hyperreflexia habitually seen in patients with pyramidal syndrome is due to lesions of other
descending pathways, such as the cortico reticulospinal pathways, which participate in
voluntary movements.It is now known that an endocannabinoid system acts in humans by at least
two types of cannabinoids receptors, CB1 and CB2. There is evidence to support the view that
the psychoactive ingredient in cannabis, delta 9-tetrahydrocannabinol (delta 9-THC), and
cannabinoids in general, can reduce muscle spasticity in people with MS. Aim of the study
will be to evaluate the effect of Sativex on: (i) patterns of brain activation associated
with movement (fMRI) in MS patients suffering from spasticity; (ii) changes in level of
spasticity (H-reflex); (iii) changes in intracortical excitability and on synaptic
intracortical network of the motor areas (double shock TMS).