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

Early Phase 1

Not yet recruiting

• Conditions: Neurodevelopmental Disorders; Cerebral Palsy
• Interventions: Drug: Modafinil; Other: Placebo; Drug: Methylphenidate

• Registration Number: NCT05675098
• Lead Sponsor: Kuwait University

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.

Study Timeline

• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08
• Study Start: 2023-05-01
• Primary Completion: 2025-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
2-Minutes Walking Test (normal pace)	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention	To determine changes in fatigue
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
Body height	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention	To determine body height
Timed up and go (TUG)	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention	To assess dynamic balance
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

Trial Locations

Locations (1)

Physical Medicine and Rehabilitation Hospital; 🇰🇼 Kuwait, Kuwait