Central Nervous System Stimulants and Physical Function in Children With Cerebral Palsy

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.

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)