Cerebral Palsy, Neurodevelopmental Disorders
Conditions
Keywords
methylphenidate, Modafinil, physical therapy, motor performance, spasticity, physical function
Brief summary
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
DRUGMethylphenidate
This medication is a psychostimulant medication and is usually prescribed for individuals with Attention-Deficit/Hyperactivity Disorder to manage ADHD behavioral symptoms
DRUGModafinil
This medication is a Central Nervous System stimulant and is usually used to treat neurological conditions, including Narcolepsy
OTHERPlacebo
Participant will receive placebo tablets (Methylphenidate and Modafinil shape)
Sponsors
Kuwait University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross motor function measure (GMFM) | Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention | To determine changes in functional motor abilities. |
| Modified Ashworth Scale (MAS) | Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention | To determine changes in spasticity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Five times sit to stand test (5x Sit-To-Stand Test /5XSST) | Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention | To assess the change in functional strength |
| Modified clinical test for sensory interaction of balance (MCTSIB) | Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention | To assess static balance |
| Ten-meter walk test (10MWT) (normal pace) | Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention | To assess change in gait speed |
| Body height | Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention | To determine body height |
| The University of California, San Diego Shortness of Breath Questionnaire (UCSDSOBQ) | Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention | To determine changes in respiratory function |
| Body weight | Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention | To determine body weight |
| 2-Minutes Walking Test (normal pace) | Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention | To determine changes in fatigue |
| Timed up and go (TUG) | Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention | To assess dynamic balance |
Countries
Kuwait
Outcome results
None listed