Lead Investigator: Viola Pongratz, Technical University Munich
Title of Proposal Research: Monitoring of upper extremity motor function in Multiple Sclerosis the nine-hole-peg-test in MS revisited
Vivli Data Request: 9132
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Multiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system, that can lead to serious disability in young adults. Worldwide, 2.9 million people are affected. Immunomodulatory drugs modulate the immune system and can effectively prevent MS relapses. However, beyond relapses, a slowly progressing disability, also termed “smoldering MS”, affects a majority of MS patients. Effective treatment options and sensitive clinical markers are still needed to tackle smoldering MS.
The 9-Hole Peg Test is part of the Multiple Sclerosis functional composite (MSFC). It measures the time it takes a person to insert and remove nine pegs from a peg board. First, the dominant hand is tested two times, followed immediately by two tests of the non-dominant hand. For scoring, it is intended to average the four trials.
Here, we use the 9-Hole Peg Test to measure performance of each hand from the same subject at multiple points in time.
The question whether the non-dominant side of the body could deteriorate faster in MS was raised by two of our patients as a consequence of their own observation in a large group of patients. To answer this question, we analyzed our own 9-Hole Peg Test follow-up data (509 patients, mean follow-up time 8.8. years) by a mixed model with nested random effects.
A mixed model is a statistical model containing both fixed (i.e. constant) effects and random effects. Nested random effects assume that there is some kind of hierarchy in the grouping of the observations.
Indeed, we could show a significant stronger deterioration of the non-dominant hand compared to the dominant hand over the course of the disease. With our data request we aim to validate this finding in an independent patient cohort.
Objective:
To investigate changes of 9-Hole Peg Test over the disease course separately for each hand in a large cohort of patients with MS in different disease stages.
Perspective:
If our finding of stronger deterioration of the non-dominant hand can be replicated, the current practice to average 9-Hole Peg Test from both hands needs to be reconsidered to monitor disease progression more accurately. A separate analysis of both hands seems appropriate.
Furthermore, a stronger deterioration of the non-dominant side of the body would be a new finding in multiple sclerosis and therefore very relevant for clinicians, researchers and patients.
Requested Studies:
A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Data Contributor: Biogen
Study ID: NCT00451451
Sponsor ID: 109MS302
A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis
Data Contributor: Roche
Study ID: NCT01247324
Sponsor ID: WA21092
A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy
Data Contributor: Sanofi
Study ID: NCT00548405
Sponsor ID: CAMMS32400507
A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301
Data Contributor: Biogen
Study ID: NCT01797965
Sponsor ID: 205MS303
A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis
Data Contributor: Sanofi
Study ID: NCT00530348
Sponsor ID: CAMMS323
A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
Data Contributor: Roche
Study ID: NCT01412333
Sponsor ID: WA21093