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Psychostimulant Medications for Physical Function and Spasticity in Children With Cerebral Palsy: Protocol for a
Mansour Alotaibi1,2, Anwar B Almutairi3, Saleh Alhirsan4
1Department of Rehabilitation, Faculty of Applied Medical Sciences, Northern Border University, Arar, Saudi Arabia.
Insights
This pilot study will investigate if central nervous system stimulant medications like methylphenidate and modafinil can safely improve motor function and reduce spasticity in children with cerebral palsy (CP). Findings may guide future treatments for pediatric CP.
Area of Science:
- Neurology
- Pediatrics
- Clinical Trials
Background:
- Cerebral palsy (CP) is a common disorder affecting movement, posture, and balance in children.
- Current treatments for CP motor impairments have limitations and side effects.
- Central nervous system (CNS) medications show potential for improving motor performance in CP.
Purpose of the Study:
- To outline a protocol for a pilot randomized controlled trial (RCT).
- To assess the safety, tolerability, and efficacy of methylphenidate (MPH) and modafinil in children with CP.
- To evaluate the impact of these medications on spasticity and motor function.
Main Methods:
- A triple-masked, placebo-controlled pilot RCT involving 36 children with CP (Gross Motor Function Classification System levels I-II, ages 7-12).
- Participants randomized into three groups: MPH, modafinil, or placebo, combined with 12 weeks of physical therapy.
- Primary outcomes: Gross Motor Function Measure-66 and Modified Ashworth Scale; secondary outcomes include various motor and balance tests.
Main Results:
- The study protocol has received ethical approval from Kuwait University and the Ministry of Health.
- Participant recruitment is scheduled to commence in June 2024.
Conclusions:
- This study addresses a gap in research regarding the combined use of CNS stimulant medications and rehabilitation for CP.
- Results may indicate the benefit of CNS stimulants in reducing spasticity and enhancing physical function in children with spastic CP.
Background:
Cerebral palsy (CP) is a prevalent nonprogressive disorder that leads to impaired movement (ie, spasticity), posture, and balance, which affects functions such as walking and upper extremity tasks. Current medical treatments show efficacy in improving motor performance but have considerable side effects. Emerging off-label use of central nervous system (CNS) medications for improving motor performance has shown promising results in children with CP and other populations.
Objective:
The aim of this study is to describe a protocol for a pilot randomized controlled trial (RCT) to examine the safety, tolerability, and efficacy of methylphenidate (MPH) and modafinil on spasticity and motor performance in children with CP.
Methods:
This will be a protocol study for a pilot, triple-masked, placebo-controlled RCT (a 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 or II based on the Gross Motor Function Classification System and be aged between 7 and 12 years. Thirty-six children with CP will be randomized into 3 groups to receive (1) MPH (2.5 mg of MPH + 100 mg placebo), (2) modafinil (100 mg modafinil + 2.5 mg placebo), or (3) a placebo (2.5 mg placebo + 100 mg placebo), in addition to physical therapy for 12 weeks. Primary outcomes include the Gross Motor Function Measure-66 and the Modified Ashworth Scale. Secondary outcomes include the Timed Up and Go test, 5 Time Sit to Stand test, Modified Clinical Test for Sensory Interaction of Balance, and 10-Meter Walk Test.
Results:
The protocol has been accepted by Kuwait University (VDR/EC-225) and the Ministry of Health of Kuwait (2022/2157). The inclusion of participants will start in June 2024.
Conclusions:
The combination of CNS stimulant medications and 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.
Trial Registration:
ClinicalTrials.gov NCT05675098; https://clinicaltrials.gov/study/NCT05675098.
International Registered Report Identifier (Irrid):
PRR1-10.2196/53728.
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