Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 17, 2023
Date Accepted: Feb 9, 2024
Psychostimulant Medications for Physical Function and Spasticity in Children with Cerebral Palsy: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Cerebral palsy (CP) is prevalent non-progressive disorder that leads to impairment of movement (i.e., spasticity), posture, and balance, which affects movements that are required for functioning, such as walking and upper extremity tasks. Current medical treatments showed efficacy in improving motor performance but have considerable side effects. Emerging off-label use of central nervous system (CNS) medications for improving motor performance showed promising results in children with CP and other populations.
Objective:
The aim of this study was to describe a protocol for a pilot randomized controlled trial (RCT) to examine safety, tolerability, and efficacy of methylphenidate (MPH) and modafinil on spasticity and motor performance in children with CP.
Methods:
A protocol study for a pilot, triple-masked, and placebo controlled RCT (class I trial following the American Academy of Neurology criteria) with blinded patients, outcome assessors, and intervention delivery team. Eligible children should be diagnosed with CP levels I and II based on the gross motor function classification system aged between seven and 12 years. Thirty-six children with CP will be randomized into three groups to receive: a) MPH (2.5 mg of MPH + 100 mg placebo), b) modafinil (100mg modafinil + 2.5 placebo), and c) placebo group (2.5 mg and 100 mg placebo), in addition to physical therapy for 12. Primary outcomes include the gross motor function measure-66 and the modified Ashworth scale. Secondary outcomes include the timed-up and go, five time sit to stand test, modified clinical test for sensory interaction of balance, and ten-meter walk tests.
Results:
The protocol has been accepted by Kuwait University (VDR/EC-225) and Ministry of Health at the states of Kuwait (2022/2157). The inclusion of participants will start in January 2024.
Conclusions:
The combination of CNS stimulant medications while controlling for rehabilitation has not been studied yet. The findings of this study may determine if using CNS stimulant medications is beneficial for the reduction of spasticity and improvement of physical function in children with spastic CP. Clinical Trial: This trial was registered in clinicaltrials.gov (NCT05675098).
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.