Highlights
- •Robotic neurorehabilitation plus OAT may be effective in improving MS spasticity.
- •We tested the efficacy of Nabiximols with OAT and neurorobotics.
- •The coupled therapy may shape common neuroplasticity mechanisms for spasticity.
- •The coupled therapy is preliminarily demonstrated as safe and efficacious.
Abstract
Background
Multiple sclerosis (MS) is an autoimmune demyelinating disease of the central nervous
system, affecting ambulation even in people with only mild neurological signs. Patients
with MS frequently experience spasticity, which contributes significantly to impair
their motor functions, including ambulation, owing to muscle stiffness, spasms, and
pain.
Objectives
To clarify the role of delta-9-tetrahydrocannabinol(THC):cannabidiol(CBD) oromucosal
spray, coupled to robot-aided gait training (RAGT) using the Lokomat©Pro to improve
functional ambulation in patients with MS.
Methods
We compared 20 patients with MS, who were treated with THC:CBD oromucosal spray in
add-on to the ongoing oral antispastic therapy (OAT) (group A), with 20 individuals
with MS (matched for clinical-demographic characteristics) who were treated only with
OAT (group B). Both the groups underwent RAGT using the Lokomat-Pro (three 45-minute
sessions per week). Our primary outcome measures were the Functional Independence
Measure (FIM) and the 10 meters walking test (10MWT). As secondary outcome measures
we evaluated the brain cortical excitability by using Transcranial Magnetic Stimulation.
Both parameters were taken before and after the end of the RAGT.
Results
FIM improved in group A more than in group B (p<0.001). Moreover, 10MWT decreased
in group A more than in group B (p<0.001). These clinical findings were paralleled
by a more evident reshape of intracortical excitability in both upper and lower limbs,
as suggested by motor evoked potential amplitude increase (p<0.001), intracortical
inhibition strengthening (p<0.001), and intracortical facilitation decrease (p=0.01)
in group A as compared to group B.
Conclusions
Our results suggest that the combined THC:CBD-RAGT approach could be useful in improving
gait performance in patients with MS.
Keywords
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Article info
Publication history
Published online: May 16, 2020
Accepted:
May 2,
2020
Received in revised form:
March 3,
2020
Received:
October 21,
2019
Identification
Copyright
© 2020 Elsevier B.V. All rights reserved.