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The Role of SAtivex® in Robotic-Rehabilitation

NCT03186664 · IRCCS Centro Neurolesi Bonino Pulejo · Updated 26 July 2019

What is being tested
Lokomat training; Sativex
For
Rehabilitation
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 65 years. About 40 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 28 Dec 2016, ends June 2018. Registered 14 June 2017.
Results
None posted yet.

In the researchers' words

Spasticity is frequently experienced by people with Multiple Sclerosis (MS), negatively impacting on patient's motor functional outcome, including walking. Currently, none of the available MS disease-modifying medications has been shown to stop or reverse gait disability. Recently the nabiximols has been tested for the treatment of spasticity and walking impairment in MS. Nabiximols (trade name Sativex®) is an oromucosal spray formulation containing 1:1 fixed ratio of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) derived from cloned Cannabis sativa L. plant. The main active substance, THC, acts as a partial agonist at human cannabinoid receptors (CB1 and CB2), and may modulate the effects of excitatory (glutamate-GLU-) and inhibitory (gamma-aminobutyric acid -GABA-) neurotransmitters, leading to muscle relaxation, which in turn is responsible for spasticity improvement. Cannabinoid receptors may modulate both excitatory and inhibitory transmission at central synapses, and have been heavily implicated, in animal models, in multiple forms of synaptic plasticity, such as long-term potentiation (LTP) and long-term depression (LTD). Indeed, in a previous study implying transcranial magnetic stimulation (TMS) technique, it has been hypothesized that the activation of cannabinoid receptors by Sativex® could modulate the balance between LTP and LTD like plasticity by…
ClinicalTrials.gov, NCT03186664

Sites

  • IRCCS Centro Neurolesi Bonino-Pulejo"Messina, Sicily, Italy