Central Nervous System Stimulants and Physical Function in Children With Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methylphenidate, Modafinil, Placebo.
- Who it may be relevant to
- Registry conditions: Neurodevelopmental Disorders, Cerebral Palsy. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kuwait
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Central Nervous System Stimulants on Physical Function in Children With Cerebral Palsy: A Pilot Randomized Controlled Trial
Overview
The purpose of this study is to determine the effects of Central Nervous System Stimulants, represented by Methylphenidate and Modafinil, compared to placebo control on motor performance in children with Cerebral Palsy. This study will be a triple-masked study per the American Academy of Neurology guidelines for clinical trials.
Detailed description
Cerebral Palsy (CP) is a neurological disorder that commonly cause disability and limit physical function in children, and this disability persists into adulthood. There are several treatment options for motor impairments associated with CP, including oral medications (diazepam or related benzodiazepines, baclofen, dantrolene, and tizanidine hydrochloride), intraspinal infusion (baclofen), paralyzing agents (Botulinum toxin), and surgical interventions (dorsal rhizotomy). However, these interventions have drawbacks that could impact their benefits, such as drowsiness with oral medications and permanent change in muscle tone with the rhizotomy surgery. Other rehabilitation interventions showed significant improvements in motor function such as constraint-induced movement therapy (CIMT) and strength training. A few researchers attempted using central nervous system stimulants (i.e., Modafinil \[Provigil\]) off-label for improving motor control and reducing spasticity in children with CP. Another medication that has been used for motor impairments is Methylphenidate (MPH), also a central nervous system stimulant. However, this medication was used for improving muscle tone and motor performance in children with Attention-deficit/Hyperactivity Disorder (ADHD), but not in children with CP. MPH is useful for children with combined CP and ADHD and showed beneficial results for ADHD symptoms and behavioral outcomes with minimal side effects. Therefore, the purpose of this pilot randomized controlled trial (RCT) is to examine the effects of Central Nervous System (CNS) stimulants (Modafinil and MPH) vs. placebo in addition to physical therapy intervention on gross motor function and spasticity in children with CP.
Interventions
- Drug Methylphenidate
This medication is a psychostimulant medication and is usually prescribed for individuals with Attention-Deficit/Hyperactivity Disorder to manage ADHD behavioral symptoms - Drug Modafinil
This medication is a Central Nervous System stimulant and is usually used to treat neurological conditions, including Narcolepsy - Other Placebo
Participant will receive placebo tablets (Methylphenidate and Modafinil shape)
Primary outcome measures
- Gross motor function measure (GMFM) [Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
- Modified Ashworth Scale (MAS) [Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
Secondary outcome measures (8)
- Body height [Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
- Timed up and go (TUG) [Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
- Five times sit to stand test (5x Sit-To-Stand Test /5XSST) [Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
- Modified clinical test for sensory interaction of balance (MCTSIB) [Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
- Ten-meter walk test (10MWT) (normal pace) [Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
- 2-Minutes Walking Test (normal pace) [Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
- The University of California, San Diego Shortness of Breath Questionnaire (UCSDSOBQ) [Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
- Body weight [Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]
Eligibility criteria
Inclusion criteria
- Children diagnosed with spastic diplegic or quadriplegic CP by a physician.
- Children aged between 7-12 years old.
- Children with CP classified as level I \& II based on the gross motor function classification system (GMFCS).
- Children with CP that are receiving physical therapy for ≥ 3 months.
Exclusion criteria
- Children that had a seizure attack in the past 6 months
- Children that have been diagnosed with attention deficit/ hyperactivity disorder (ADHD)
- Children that had any surgery within the last 6 months
- Children that has lower-extremity contractures determined by the passive range of motion (hips, knees, and ankles)
- Children that use medications that interfere with spasticity (e.g., Baclofen)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Kuwait · 1 center
- Physical Medicine and Rehabilitation Hospital — Kuwait City
Publications
- Alotaibi M, Almutairi AB, Alhirsan S, Alkazemi A, Alharbi M, Alrashdi N, Taqi A, Alamiri B, Vogtle L, Alqahtani MM. Psychostimulant Medications for Physical Function and Spasticity in Children With Cerebral Palsy: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 5;13:e53728. doi: 10.2196/53728. PMID 38441919
Identifiers
NCT: NCT05675098 · IRB-2157/2022