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

Kuwait University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Cerebral Palsy; Neurodevelopmental Disorders

Treatments: Drug: Modafinil; Other: Placebo; Drug: Methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT05675098

IRB-2157/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Methylphenidate

Experimental group

Description:

Participants in this group will receive 2.5mg Methylphenidate and 100mg placebo (Modafinil shape) in addition to physical therapy program

Treatment:

Drug: Methylphenidate

Modafinil

Experimental group

Description:

Participants in this group will receive 100mg Modafinil and 2.5mg placebo (Methylphenidate shape) in addition to physical therapy program

Treatment:

Drug: Modafinil

Placebo

Placebo Comparator group

Description:

Participants in this group will receive 2.5mg placebo (Methylphenidate shape) and 100mg placebo (Modafinil shape) in addition to physical therapy program

Treatment:

Other: Placebo