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The role of Sativex in robotic rehabilitation in individuals with multiple sclerosis: Rationale, study design, and methodology.

ABSTRACT: Currently, none of the available multiple sclerosis (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 and cannabidiol derived from cloned Cannabis sativa L. plant.A single-center, prospective, parallel design, single-blind trial will be conducted at the IRCCS Neurolesi "Bonino-Pulejo" (Italy) involving MS patients affected by spasticity and undergoing a Robotic Rehabilitation training. The aim of the study is to clarify the role of Sativex coupled to a robotic neurehabilitation training in MS patients in improving motor outcomes, by means of clinical, kinematic, and neurophysiological measures. Patients will be randomly divided in 2 groups: one taking only an oral antispastic drug and the other with Sativex in add-on. After 1 month, we will evaluate the response to Sativex (responder patients' amelioration >20% at MRS score) enrolling into the study the first 20 patients with a good response to Sativex, whereas other 20 no-responder individuals will continue their antispastic drug. All the 40 subjects, were divided into 2 groups (A: Sativex?+?Lokomat Training, and B: other antispastic+Lokomat Training), will perform a neurorobotic-assisted gait training (each session will last at least 45 minutes, 3 times per week, for a total of 20 sessions). All the patients will undergo a complete physical and neurological examination at baseline, at the end of the robotic training (T1), and 30 days after the end of the neurorehabilitation training (T2).

SUBMITTER: Russo M

PROVIDER: S-EPMC5704890 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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The role of Sativex in robotic rehabilitation in individuals with multiple sclerosis: Rationale, study design, and methodology.

Russo Margherita M Dattola Vincenzo V Logiudice Anna Lisa AL Ciurleo Rosella R Sessa Edoardo E De Luca Rosaria R Bramanti Placido P Bramanti Alessia A Naro Antonino A Calabrò Rocco Salvatore RS

Medicine 20171101 46

<h4>Introduction</h4>Currently, none of the available multiple sclerosis (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 and cannabidiol derived from cloned Cannabis sativa L. plant.<h4>Method and analysis</h4>A single-center, prospe ...[more]

PMID: 29145345

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Project description:BACKGROUND: Although there is substantial anecdotal evidence that clutter is common among people with multiple sclerosis (MS), the literature contains no reports of studies on the actual prevalence of the problem or its impact on functional performance in this population. Clutter promotes confusion and places individuals in potentially dangerous situations by increasing their risks of falling, losing medications, and misplacing important documents. In addition, it may negatively affect activities of daily living (ADLs). Many common MS symptoms such as decreased mobility, visual or cognitive changes, fatigue, and depression can exacerbate clutter accumulation, which in turn can have detrimental effects on physical, financial, emotional, cognitive, and social functioning. It is critical for MS clinicians to address clutter management in order to improve patients' overall functional independence and participation. METHODS: A clutter reduction protocol was developed and implemented at our institution for individuals with MS. Our group program addresses psychosocial issues preventing organization and offers practical strategies for clutter removal and management to improve performance in ADLs. A clutter questionnaire is administered to individuals before and after their participation in the group program. RESULTS: Anecdotal reports indicate that the intervention helped to reduce clutter, promote a more realistic attitude toward "possessions," and establish a sense of accomplishment in controlling one's environment. Participants also reported fewer falls, feeling less isolated, increased ease in finding their medications, and a general sense of cognitive clarity in accomplishing ADLs. Outcome assessments are now being developed to objectively measure these effects as well as the prevalence of clutter within the MS population. CONCLUSIONS: Clutter management is an important area for MS clinicians to address because it can significantly affect patients' functioning, safety, performance of ADLs, and quality of life.

Project description:BackgroundNeurological disability progression occurs across the spectrum of people living with multiple sclerosis (MS). Although there are a handful of disease-modifying treatments approved for use in progressive phenotypes of MS, there are no treatments that substantially modify the course of clinical progression in MS. Characterizing the determinants of clinical progression can inform the development of novel therapeutic agents and treatment approaches that target progression in MS, which is one of the greatest unmet needs in clinical practice. Canada, having one of the world's highest rates of MS and a publicly-funded health care system, represents an optimal country to achieve in-depth analysis of progression. Accordingly, the overarching aim of the Canadian Prospective Cohort Study to Understand Progression in MS (CanProCo) is to evaluate a wide spectrum of factors associated with the clinical onset and rate of disease progression in MS, and to describe how these factors relate to one another to influence progression.MethodsCanProCo is a prospective, observational cohort study with investigators specializing in epidemiology, neuroimaging, neuroimmunology, health services research and health economics. CanProCo's study design was approved by an international review panel, comprised of content experts and key stakeholders. One thousand individuals with radiologically-isolated syndrome, relapsing-remitting MS, and primary-progressive MS within 10-15 years of disease onset will be recruited from 5 academic MS centres in Canada. Participants will undergo detailed clinical evaluation annually over 5 years (including advanced, app-based clinical data collection). In a subset of participants within 5-10 years of disease onset (n = 500), blood, cerebrospinal fluid, and research MRIs will be collected allowing an integrated, in-depth evaluation of factors contributing to progression in MS from multiple perspectives. Factors of interest range from biological measures (e.g. single-cell RNA-sequencing), MRI-based microstructural assessment, participant characteristics (self-reported, performance-based, clinician-assessed, health-system based), and micro and macro-environmental factors.DiscussionHalting the progression of MS remains a fundamental need to improve the lives of people living with MS. Achieving this requires leveraging transdisciplinary approaches to better characterize why clinical progression occurs. CanProCo is a pioneering multi-dimensional cohort study aiming to characterize these determinants to inform the development and implementation of efficacious and effective interventions.

Dataset Information

The role of Sativex in robotic rehabilitation in individuals with multiple sclerosis: Rationale, study design, and methodology.

Publications

The role of Sativex in robotic rehabilitation in individuals with multiple sclerosis: Rationale, study design, and methodology.

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