Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol

BACKGROUND: Chronic fatigue and inactivity are prevalent problems among individuals with multiple sclerosis (MS) and may independently or interactively have detrimental effects on quality of life and ability to participate in life roles. However, no studies to date have systematically evaluated the benefits of an intervention for both managing fatigue and promoting physical activity in individuals with MS. This study involves a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals with MS in managing fatigue and increasing physical activity levels. METHODS/DESIGN: A randomly-allocated, three-parallel group, time-series design with a social support program serving as the control group will be used to accomplish the purpose of the study. Our goal is to recruit 189 ambulatory individuals with MS who will be randomized into one of three telehealth interventions: (1) a contact-control social support intervention, (2) a physical activity-only intervention, and (3) a physical activity plus fatigue management intervention. All interventions will last 12 weeks and will be delivered entirely over the phone. Our hypothesis is that, in comparison to the contact-control condition, both the physical activity-only intervention and the physical activity plus fatigue management intervention will yield significant increases in physical activity levels as well as improve fatigue and health and function, with the physical activity plus fatigue management intervention yielding significantly larger improvements. To test this hypothesis, outcome measures will be administered at Weeks 1, 12, and 24. Primary outcomes will be the Fatigue Impact Scale, the Godin Leisure-Time Exercise Questionnaire (GLTEQ), and Actigraph accelerometers. Secondary outcomes will include the SF-12 Survey, Mental Health Inventory, Multiple Sclerosis Impact Scale, the Community Participation Indicator, and psychosocial constructs (e.g., self-efficacy). DISCUSSION: The proposed study is novel, in that it represents a multi-disciplinary effort to merge two promising lines of research on MS: fatigue management and physical activity promotion. Collectively, the proposed study will be the largest randomized controlled trial to examine the effects of a lifestyle physical activity intervention in people with MS. TRIAL REGISTRATION: NCT0157271

Prevalence of Stress Urinary Incontinence in Women with Multiple Sclerosis

Purpose The purpose of this study was to determine the prevalence of stress urinary incontinence (SUI) in women with multiple sclerosis (MS) and to what degree these women are bothered by their SUI, since there is a paucity of literature regarding the nature of SUI in this unique population of women. Methods We conducted a prospective Institutional Review Board approved study. Women scheduled for outpatient follow-up appointments at a dedicated MS center were asked to complete a questionnaire regarding urinary incontinence. Urgency urinary incontinence (UUI) and SUI were defined as an answer of slightly, moderately or greatly to the Urogenital Distress Inventory (UDI-6) question #2 and question #3, respectively. Impact of SUI on physical activity was determined by Incontinence Impact Questionnaire (IIQ-7) question #2. Results A total of 55.9% (80/143) women had SUI, 70.6% (101/143) women had UUI, and 44.8% (64/143) women had mixed urinary incontinence. The mean age was 45.8 years old (range, 20 to 72 years). Women with SUI were significantly older (mean, 47.2 vs. 41.9; P=0.023) and there was a trend towards a greater body mass index (mean, 29.3 vs. 26.5; P=0.057). Women with SUI had significantly higher IIQ-7 scores compared to women without SUI (P<0.001). Impact of urinary incontinence on physical activity was also found to be significantly greater in women with SUI (mean IIQ-7 question #2, 0.96 vs. 0.35; P<0.001). Conclusions The prevalence of SUI in women with MS is 55.9% and the presence of SUI has a significant impact on their quality of life. A comprehensive urologic evaluation of a woman with MS should include assessment of SUI

Local tomography and focal mechanisms in the south-western Alps: Comparison of methods and tectonic implications

International audienceWe investigate how focal solutions and hypocenter locations may depend on the ray tracing algorithm and the strategy of velocity inversion. Using arrival times from a temporary seismological network in the south-western Alps, a local earthquake tomography has been performed by Paul et al. [Paul, A., Cattaneo, M., Thouvenot, F., Spallarossa, D., Béthoux, N., and Fréchet, J., 2001. A three-dimensional crustal velocity model of the south-western Alps from local earthquake tomography. J. Geophys. Res. 106, 19367–19390.] with the method developed by Thurber [Thurber, C.H., 1993. Local earthquake tomography: velocity and Vp/Vs-Theory, in Seismic Tomography: Theory and practice, Iyer, H.M., and Irahara eds., Chapman and Hall, New York, 563–583.]. Another inversion of the same data set is performed here using a different tomography code relying on a shooting paraxial method and cubic interpolation of velocities. The resulting images display the same main features, although Thurber's code appears to be more robust in regions with scarce ray coverage and strong velocity contrasts. Concerning hypocenter location in Piemont units, one major result is the concentration of hypocenters at the boundary between the mantle wedge of the Ivrea body and the European crust. Forty-six focal mechanisms are shown that were computed using both the take-off angles in the minimum 1-D model and in the 3-D velocity structures resulting from the two inversions. The sets of focal solutions are very similar, proving the reliability and the coherency of the focal solutions. The widespread extension in the core of the western Alps is confirmed whereas a few compressive solutions are found east of the Piemont units. These results constrain the sharp change of stress tensor and evidence a decoupling of strain beneath the east of Dora Maira massif up to beneath the north of Argentera massif. On a geodynamical point of view seismicity and focal mechanism distribution are compatible with the present day models published for the western Alps, where the major feature is the lithospheric thickening [Schmid, S.M., and Kissling, E., 2000. The arc of the western Alps in the light of geophysical data on deep crustal structure. Tectonics, 19, 62–85.], implying widespread extension in the core of the western Alps [Sue, C., Thouvenot, F., Fréchet, J., and Tricart, P., 1999. Widespread extension in the core of the western Alps revealed by earthquake analysis. J. Geophys. Res., 104, 25611–25622.]. However the existence of compressive events dealing at depth with the boundary of Ivrea body allows to postulate that this geological structure is still tectonically active. Even if field work has not shown this so far, the Insubric line appears to extend toward the south at depth, as a blind fault, and to play a key role in the dynamics of the south-western Alp

Adapting the multiple sclerosis functional composite for telehealth administration using videoconference delivery : methodological considerations and interrater reliability

Objective: To describe the adaptations made and to examine interrater reliability and feasibility of administering a telehealth version of the Multiple Sclerosis Functional Composite (tele-MSFC). Design: The Multiple Sclerosis Functional Composite (MSFC) is a commonly used, in-person clinical outcome assessment. It is composed of the timed 25-Foot Walk Test (T25FWT), Nine-Hole Peg Test (NHPT), and Paced Auditory Serial Addition Test (PASAT). The MSFC was adapted for videoconference administration as part of a larger clinical trial. One of the adaptations included administering a timed 12.5-Foot Walk Test (T12.5FWT) for participants who did not have adequate space in their homes for the T25FWT. Participants, examiners, and raters completed surveys online about their satisfaction and experience with tele-MSFC. Setting: Participants underwent the tele-MSFC in their homes using a laptop or smartphone while examiners scored the tele-MSFC in real-time at a remote location. Participants: Community-dwelling adults (n=61) with mild-to-moderate multiple sclerosis (MS) symptoms. Interventions: Not applicable. Main Outcome Measure: Tele-MSFC. Results: Intraclass correlation coefficients (ICC) assessed interrater reliability between the examiner and 2 independent raters who later scored a recording of the tele-MSFC. Interrater reliability was excellent (ICC&gt;0.90) for all tests, including the T12.5FWT. Participants were highly satisfied with tele-MSFC. However, challenges included adequate space for T25FWT, technical difficulties, and safety and privacy considerations of individuals with moderate impairments who were requested to have their caregivers present during testing. Conclusion: The tele-MSFC is reliable and feasible to administer with adaptations for community-dwelling adults with mild to moderate MS symptoms. Further validation of T12.5FWT is needed

Intrathecal baclofen in multiple sclerosis: Too little, too late?

The majority of patients with multiple sclerosis (MS) have symptoms of spasticity that increasingly impair function as the disease progresses. With appropriate treatment, however, quality of life can be improved. Oral antispasticity medications are useful in managing mild spasticity but are frequently ineffective in controlling moderate to severe spasticity, because patients often cannot tolerate the adverse effects of increasing doses. Intrathecal baclofen (ITB) therapy can be an effective alternative to oral medications in patients who have a suboptimal response to oral medications or who cannot tolerate dose escalation or multidrug oral regimens. ITB therapy may be underutilized in the MS population because clinicians (a) are more focused on disease-modifying therapies rather than symptom control, (b) underestimate the impact of spasticity on quality of life, and (c) have concerns about the cost and safety of ITB therapy. Delivery of ITB therapy requires expertly trained staff and proper facilities for pump management. This article summarizes the findings and recommendations of an expert panel on the use of ITB therapy in the MS population and the role of the physician and comprehensive care team in patient selection, screening, and management

The Use of Telerehabilitation to Improve Movement-Related Outcomes and Quality of Life for Individuals With Parkinson Disease: Pilot Randomized Controlled Trial

BackgroundIndividuals with Parkinson disease (PD) can improve their overall mobility and participation in daily activities as they engage in frequent exercise. Despite the need for individually tailored exercises, persons with PD often face barriers to accessing physical rehabilitation professionals who can provide them. Telerehabilitation (TR) may facilitate access to necessary and individually tailored rehabilitation for individuals with PD. ObjectiveThe purpose of this study was to assess the feasibility of TR for individuals with PD and explore clinical outcomes compared to in-person care. MethodsThis was a pilot randomized controlled trial conducted at 2 outpatient neurorehabilitation clinics with 3 study groups: clinic+TR, TR-only, and usual care (UC). TR was administered using a web-based application with a mobile app option. One-hour interventions were performed weekly for 4 weeks, in-person for the clinic+TR and UC groups and virtually for the TR-only group. Home exercises were provided on paper for the UC group and via the web-based platform for the clinic+TR and TR-only groups. Feasibility was assessed by recruitment and retention success and patient and therapist satisfaction, as rated in surveys. Clinical outcomes were explored using performance and patient-reported measures in between- and within-group analyses. ResultsOf 389 patients screened, 68 (17.5%) met eligibility criteria, and 20 (29.4% of those eligible) were enrolled (clinic+TR, n=6; TR-only, n=6; and UC, n=8). One patient (TR-only) was withdrawn due to a non–study-related injurious fall. Regardless of group allocation, both patients and therapists generally rated the mode of care delivery as “good” or “very good” across all constructs assessed, including overall satisfaction and safety. In the analysis of all groups, there were no differences in clinical outcomes at the discharge visit. Within-group differences (from baseline to discharge) were also generally not significant except in the UC group (faster 5-time sit-to-stand time and higher mini balance evaluation systems test balance score) and clinic+TR group (higher mini balance evaluation systems test balance score). ConclusionsHigh satisfaction amongst patients and clinicians regardless of group, combined with nonsignificant between-group differences in clinical outcomes, suggest that TR is feasible for individuals with PD in early-moderate stages. Future trials with a larger sample are necessary to test clinical effectiveness. As larger trials enroll patients with diverse characteristics (eg, in terms of age, disease progression, caregiver support, technology access and capacity, etc), they could begin to identify opportunities for matching patients to the optimal utilization of TR as part of the therapy episode. Trial RegistrationClinicalTrials.gov NCT06246747; https://clinicaltrials.gov/study/NCT0624674

Measurement error and reliability of TMS metrics collected from biceps and triceps in individuals with chronic incomplete tetraplegia

Transcranial magnetic stimulation (TMS) is used to investigate corticomotor neurophysiology associated with functional recovery in individuals with spinal cord injury (SCI). There is insufficient evidence about test–retest measurement properties of TMS in SCI. Therefore, we investigated test–retest agreement and reliability of TMS metrics representing corticomotor excitability, output, gain, map (representation), and inhibition in individuals with cervical SCI. We collected TMS metrics from biceps and triceps muscles because of the relevance of this proximal muscle pair to the cervical SCI population. Twelve individuals with chronic C3–C6 SCI participated in two TMS sessions separated by ≥ 2 weeks. Measurement agreement was evaluated using t tests, Bland–Altman limits of agreement and relative standard error of measurement (SEM%), while reliability was investigated using intra-class correlation coefficient (ICC) and concordance correlation coefficient (CCC). We calculated the smallest detectable change for all TMS metrics. All TMS metrics except antero-posterior map coordinates and corticomotor inhibition were in agreement upon repeated measurement though limits of agreement were generally large. Measures of corticomotor excitability, output and medio-lateral map coordinates had superior agreement (SEM% \u3c 10). Metrics representing corticomotor excitability, output, and inhibition had good-to-excellent reliability (ICC/CCC \u3e 0.75). The smallest detectable change for TMS metrics was generally high for a single individual, but this value reduced substantially with increase in sample size. We recommend use of corticomotor excitability and recruitment curve area owing to their superior measurement properties. A modest group size (20 or above) yields more stable measurements, which may favor use of TMS metrics in group level modulation after SCI

Early outcomes after intrathecal baclofen therapy in ambulatory patients with multiple sclerosis

© AANS 2018. OBJECTIVE Multiple sclerosis (MS) is a chronic autoimmune disease that causes demyelination and axonal loss. Walking difficulties are a common and debilitating symptom of MS; they are usually caused by spastic paresis of the lower extremities. Although intrathecal baclofen (ITB) therapy has been reported to be an effective treatment for spasticity in MS, there is limited published evidence regarding its effects on ambulation. The goal of this study was to characterize ITB therapy outcomes in ambulatory patients with MS. METHODS Data from 47 ambulatory patients with MS who received ITB therapy were analyzed retrospectively. Outcome measures included Modified Ashworth Scale, Spasm Frequency Scale, Numeric Pain Rating Scale, and the Timed 25-Foot Walk. Repeated-measures ANOVA was used to test for changes in outcome measures between baseline and posttreatment (6 months and 1 year). Significance was set at p \u3c 0.05. Descriptive data are expressed as the mean ± SD, and results of the repeated-measures ANOVA tests and the Wilcoxon rank-sum test are expressed as the mean ± SEM. RESULTS There was a statistically significant reduction in the following variables: 1) aggregate lower-extremity Modified Ashworth Scale scores (from 14.8 ± 1.0 before ITB therapy to 5.8 ± 0.8 at 6 months posttreatment and 6.4 ± 0.9 at 1 year [p \u3c 0.05]); 2) Numeric Pain Rating Scale scores (4.4 ± 0.5 before ITB, 2.8 ± 0.5 at 6 months, and 2.4 ± 0.4 at 1 year [p \u3c 0.05]); 3) spasm frequency (45.7% of the patients reported a spasm frequency of 1 event per hour before ITB therapy, whereas 15.6% and 4.3% of the patients reported the same at 6 months and 1 year posttreatment, respectively [p \u3c 0.05]); and 4) the number of oral medications taken for spasticity (p \u3c 0.05). Of the 47 patients, 34 remained ambulatory at 6 months, and 32 at 1 year posttreatment. There was no statistically significant change in performance on the Timed 25-Foot Walk test over time for those patients who remained ambulatory. CONCLUSIONS In this retrospective study, the authors found that ITB therapy is effective in reducing spasticity and related symptoms in ambulatory patients with MS. Because the use of ITB therapy is increasing in ambulatory patients with MS, randomized, prospective studies are important to help provide a more useful characterization of the effects of ITB therapy on ambulation

Safety, Tolerability, and Sensorimotor Effects of Extended-release Dalfampridine in Adults With Cerebral Palsy: A Pilot Study.

PURPOSE: The goal of this study was to evaluate the safety and tolerability of dalfampridine extended release (D-ER) in a pilot study of adults with cerebral palsy (CP) and limited ambulatory ability, and to explore drug effects on sensorimotor function. METHODS: An initial double-blind, single-dose crossover study was performed in 11 individuals randomized 1:1 to receive D-ER (10 mg) or placebo, followed by a 2-day washout period and the opposite treatment, with evaluation for safety and tolerability. A twice daily dosing, double-blind, placebo-controlled, crossover study was then performed. Participants were randomized in a 1:1 ratio to 1 of 2 sequences: 1 week of D-ER (10 mg BID) or placebo, followed by a 1-week washout and 1 week of the opposite treatment. Key inclusion criteria were age 18 to 70 years, body mass index 18.0 to 30.0 kg/m FINDINGS: Among the 24 total participants who were randomized to treatment and completed the twice daily dosing phase study, their mean age was 38.6 years (range, 20-62 years), 54% were women, and 83% had spastic CP. Adverse events were consistent with previous D-ER trials, most commonly headache (13% D-ER, 4% placebo), fatigue (13% D-ER, 0% placebo), insomnia (8% D-ER, 4% placebo), diarrhea (4% D-ER, 4% placebo), and nausea (4% D-ER, 4% placebo). The mixed model analysis of full crossover data identified no significant difference between D-ER and placebo in the primary functional analysis (the most pronounced deficit; P = 0.70) or in the secondary analyses (hand strength [P = 0.48], manual dexterity [P = 0.13], or walking speed [P = 0.42]). IMPLICATIONS: In this preliminary study of adults with CP, a BID dose of 10-mg D-ER was generally safe and well tolerated. The exploratory functional assessments for upper and lower sensorimotor deficits did not establish that the study population was markedly responsive to D-ER relative to placebo. These findings do not provide the proof-of-concept that would support further evaluation of D-ER as a potential intervention to improve function in adults with CP. ClinicalTrials.gov identifier: NCT01468350