Author Of 2 Presentations
LB1195 - Changes in Mobility and Brain Connectivity following over-ground Robotic Exoskeleton Rehabilitation in Persons with MS (ID 2020)
Abstract
Background
Multiple Sclerosis (MS) has an estimated prevalence of 337-362 per 100,000 people[1] and is characterized as an autoimmune disease that causes axonal degradation, leading to mobility and cognitive impairments. While physical rehabilitation has been identified as one of the best methods for restoring function in MS[2], it can be challenging to implement in individuals with severe impaired mobility. One approach is the use of a novel assistive device such as a wearable Robotic exoskeletons (RE). REs have been increasingly used to provide gait rehabilitation for persons with mobility disorders (e.g. spinal cord injury and stroke) [3-7], and more recently for persons with MS[8, 9]. The current study examines potential improvements in mobility, cognitive processing speed, as well as resting-state (RS) functional connectivity of the brain in persons with MS through the use of RE.
Objectives
To determine if gait training using RE improves mobility, cognition, and brain RS functional connectivity in persons with MS.
Methods
Four persons with relapsing-remitting MS (RRMS) participated in this randomized pilot prospective study. Two MS patients received eight 1-hour RE training sessions (Ekso-GT, Ekso Bionics, Berkley, CA, USA) administered by a licensed physical therapist; the other two participants received eight 1-hour Conventional Gait Therapy (CGT) sessions. The 8-seesion interventions occurred over a four week period (2 sessions/week). The Six Minute Walk Test (6MWT), Symbol Digit Modalities Test (SDMT), and RS functional MRI (fMRI) of the brain, acquired using a Siemens Skyra 3 Tesla MRI scanner were assessed at baseline and after the 4-week intervention. A seed-based RS functional connectivity analysis approach was used, with seeds placed in the motor and ventromedial prefrontal cortices (vmPFC).
Results
The RE group improved by 21% in walking distance in the 6MWT while the CGT group showed essentially no change (a 2% decrease in the distance). The RE group also showed improvements in SDMT performance (ZRE = 0.95; ZCGT = - 0.78), as well as improvements in functional connectivity in the motor cortex (ZRE = 0.8; ZCGT = - 0.08) and in the vmPFC (ZRE = 0.8; ZCGT = -0.003).
Conclusions
Improvements in mobility, cognitive processing speed, and resting state functional connectivity in the motor cortex and in the vmPFC were observed for participants in the RE gait training group but not in the CGT group. These pilot results suggest that gait training using RE can be an effective therapy for improving walking ability, cognitive function, and brain connectivity in resting-state networks in persons with MS. Data analysis of a larger sample is underway to confirm the findings.
P1094 - Effect of nabiximols cannabinoid oromucosal spray on depressive symptoms, suicidality, and cognition in patients with multiple sclerosis (MS) (ID 1463)
Abstract
Background
Substantial evidence has shown nabiximols, a complex botanical mixture containing delta-9-tetrahydrocannabinol and cannabidiol as the principal cannabinoids, can reduce spasticity associated with MS. This analysis assesses whether nabiximols affects other patient outcomes such as depressive symptoms, suicidality, and cognition.
Objectives
Report the effect of nabiximols on depression, suicidality, and cognition using data from 2 placebo-controlled randomized controlled trials, GWSP0604 (12 weeks) and GWMS1137 (48 weeks), in patients with spasticity due to MS.
Methods
Mood and suicidality were assessed using the Beck Depression Inventory-II (BDI-II) in both trials. In GWMS1137, suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) and working memory/processing speed using the Paced Auditory Serial Addition Test (PASAT). The combined PASAT total score was calculated combining both PASAT-3 and -2 tests scores (total of 120 points). Outcome differences between nabiximols and placebo are summarized.
Results
241 patients from GWSP0604 and 121 from GWMS1137 were included. The baseline and end-of-treatment mean BDI-II total scores were 8.7 vs 9.5 for nabiximols and 9.7 vs 10.4 for placebo in GWSP0604, and 15.7 vs 12.5 for nabiximols and 13.5 vs 11.1 for placebo in GWMS1137. Differences between nabiximols and placebo of the BDI-II change from baseline adjusted means were -0.06 (-1.62, 1.49) in GWSP0604 (no significant difference) and -0.29 (-2.91, 2.33) in GWMS1137 (statistically non-inferior). Question 9 of BDI-II (suicidal thoughts or wishes) showed no notable treatment differences in either trial, with only 1 patient treated with nabiximols reporting a score ≥2. On the Columbia-Suicide Severity Rating Scale, 3 (5.1%) patients randomized to placebo and 1 (1.6%) to nabiximols had a ‘flag’ (ie, ‘Yes’ as a response), but further questioning revealed no emergent suicidal ideations or behavior in any of these patients. For GWMS1137, the baseline and end-of-treatment PASAT total score means were 71.3 vs 78.6 for nabiximols and 74.5 vs 82.7 for placebo; increases may reflect practice effects. Treatment difference of the adjusted mean was -1.47 (-6.41, 3.48), indicating nabiximols does not adversely affect working memory/cognitive processing speed in MS patients over a 48-week period compared with placebo.
Conclusions
Nabiximols had no notable effects on depression, suicidality, or working memory/processing speed in patients with MS. Funding: Greenwich Biosciences, Inc.
Presenter Of 1 Presentation
P1094 - Effect of nabiximols cannabinoid oromucosal spray on depressive symptoms, suicidality, and cognition in patients with multiple sclerosis (MS) (ID 1463)
Abstract
Background
Substantial evidence has shown nabiximols, a complex botanical mixture containing delta-9-tetrahydrocannabinol and cannabidiol as the principal cannabinoids, can reduce spasticity associated with MS. This analysis assesses whether nabiximols affects other patient outcomes such as depressive symptoms, suicidality, and cognition.
Objectives
Report the effect of nabiximols on depression, suicidality, and cognition using data from 2 placebo-controlled randomized controlled trials, GWSP0604 (12 weeks) and GWMS1137 (48 weeks), in patients with spasticity due to MS.
Methods
Mood and suicidality were assessed using the Beck Depression Inventory-II (BDI-II) in both trials. In GWMS1137, suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) and working memory/processing speed using the Paced Auditory Serial Addition Test (PASAT). The combined PASAT total score was calculated combining both PASAT-3 and -2 tests scores (total of 120 points). Outcome differences between nabiximols and placebo are summarized.
Results
241 patients from GWSP0604 and 121 from GWMS1137 were included. The baseline and end-of-treatment mean BDI-II total scores were 8.7 vs 9.5 for nabiximols and 9.7 vs 10.4 for placebo in GWSP0604, and 15.7 vs 12.5 for nabiximols and 13.5 vs 11.1 for placebo in GWMS1137. Differences between nabiximols and placebo of the BDI-II change from baseline adjusted means were -0.06 (-1.62, 1.49) in GWSP0604 (no significant difference) and -0.29 (-2.91, 2.33) in GWMS1137 (statistically non-inferior). Question 9 of BDI-II (suicidal thoughts or wishes) showed no notable treatment differences in either trial, with only 1 patient treated with nabiximols reporting a score ≥2. On the Columbia-Suicide Severity Rating Scale, 3 (5.1%) patients randomized to placebo and 1 (1.6%) to nabiximols had a ‘flag’ (ie, ‘Yes’ as a response), but further questioning revealed no emergent suicidal ideations or behavior in any of these patients. For GWMS1137, the baseline and end-of-treatment PASAT total score means were 71.3 vs 78.6 for nabiximols and 74.5 vs 82.7 for placebo; increases may reflect practice effects. Treatment difference of the adjusted mean was -1.47 (-6.41, 3.48), indicating nabiximols does not adversely affect working memory/cognitive processing speed in MS patients over a 48-week period compared with placebo.
Conclusions
Nabiximols had no notable effects on depression, suicidality, or working memory/processing speed in patients with MS. Funding: Greenwich Biosciences, Inc.