Psychostimulant Medications for Physical Function and Spasticity in Children With Cerebral Palsy: Protocol for a...

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.