Columbia University Irving Medical Center

Author Of 2 Presentations

Clinical Trials Poster Presentation

P0190 - ASPIRE Study: Protocol for a double-blind RCT of aspirin for overheating during exercise in MS (ID 666)

Speakers
Presentation Number
P0190
Presentation Topic
Clinical Trials

Abstract

Background

Background Exercise holds many benefits for persons with multiple sclerosis (MS), yet many MS patients are heat sensitive and therefore avoid exercise due to overheating and exhaustion that result. The exercise literature in MS to date is likely subject to bias by predominant representation of patients who are not heat sensitive and may not be a representative sample. Finding ways to facilitate comfortable engagement in exercise for persons with MS is a key priority. Our pilot trial of aspirin as a cooling pretreatment for exercise in MS showed favorable results: after aspirin, participants who experience overheating during exercise were able to exercise longer and the amount of body temperature increase they experienced was reduced by 56%.

Objectives

Objective Conduct a large-scale double-blind randomized controlled trial of aspirin (acetylsalicylic acid, ASA) pretreatment as a convenient and inexpensive method to prevent overheating and improve exercise performance in persons with MS, compared to placebo and acetaminophen.

Methods

Methods Participants are seen for three separate sessions (separated by at least one week) for a laboratory maximal exercise test. At each session, body temperature is measured tympanically before oral administration of a standard adult dose (650 mg) of aspirin, acetaminophen (APAP), or placebo. Participants then perform a maximal ramp test on a cycle ergometer. Primary outcomes are (a) time to exhaustion (TTE, i.e., time spent cycling to peak exertion) and (b) body temperature change. Secondary outcomes include patient reported outcomes including pain, fatigue, and mood. Cross-over analyses will include tests for effects of treatment, period, treatment–period interaction (carryover effect) and sequence.

Results

Results Enrollment in the ASPIRE trial was begun in February 2019. Adherence and acceptability of the treatment are high. To date, 35 participants have been enrolled; of these, 16 have completed all 3 study visits. There have been 6 drop-outs and 7 non-serious adverse events. Heterogeneity of sample is notable, with 26% men, 9% Black, 6% Hispanic/Latinx. Study data will not be unblinded until completion of all participants (target N=60).

Conclusions

Conclusions Exercise is highly beneficial for persons with MS, but only if they do it. Positive findings from this trial would yield an effective, inexpensive, readily available, unobtrusive treatment to allow many more persons with MS access to the benefits of exercise via a cooling mechanism. Thus far, enrollment and adherence in the ASPIRE trial, as well as diversity of our sample suggest good acceptibiliity of aspirin as a treatment, and favorable generalizability of trial results.

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Pediatric MS Poster Presentation

P1081 - Social networks in pediatric multiple sclerosis are associated with academic performance (ID 1056)

Speakers
Presentation Number
P1081
Presentation Topic
Pediatric MS

Abstract

Background

Social connectivity is known to impact health and cognition. In adults with multiple sclerosis (MS), close-knit social networks have been associated with worsened physical function (Levin et al, ECTRIMS 2019). To date, no studies have explored social networks in pediatric MS, a disease that occurs during a period of formative learning, social exploration, and personal identity.

Objectives

To analyze social networks in a small cohort of adolescents with MS and examine how these networks relate to academic performance.

Methods

We deployed a structured social network questionnaire to 14 adolescents with MS. We assessed academic performance using either the Woodcock Johnson Test of Academic Achievement (WJ) or performance on a statewide standardized achievement test. We defined academic impairment as a z score ≤1.5 standard deviations on the WJ or a score <65 on any statewide exam. Using graph theoretical statistics, we calculated three structural metrics for each individual’s social network: size, constraint, and effective size. Size is the number of network members, excluding the patient. Constraint is the extent to which network members have connections to each other. Effective size, conceptually the inverse of constraint, is the number of members who occupy structurally unique positions. We explored the association between network size, constraint, and effective size and academic impairment using a student t test.

Results

13 out of 14 subjects (93%) were female with a mean age of 16.4 (±3.25) years. Median EDSS was 1 (range 0-3). Median grade level was 12 (range 7-14). 8 of 14 (57%) subjects were academically impaired. Subjects who were academically impaired had a lower mean network size than those without academic impairment (9.75 vs 17.2, p = 0.028). The group with academic impairment had a trend towards higher network constraint (mean 54.9 vs. 30.4, p = 0.0507). Academic impairment was associated with lower average network effective size (3.94 vs 7.16, p = 0.004).

Conclusions

In this small cohort of adolescents with MS, we found that academic performance was inversely related to social network size and effective size. Taken together, these findings suggest that small, closely-knit social networks are associated with lower scholastic performance. These social network trends in children with MS are in line with physical disability data in adults with MS. Future plans include analyzing a dataset of 60 pediatric MS subjects and comparing to healthy controls. Larger, longitudinal studies are needed to determine the full impact of social networks on academic achievement in youth with MS.

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