CP: Central Nervous System Stimulants and Physical Function in Children With Cerebral Palsy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Early Phase 1 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Methylphenidate Participants in this group will receive 2.5mg Methylphenidate and 100mg placebo (Modafinil shape) in addition to physical therapy program |
Drug: Methylphenidate
This medication is a psychostimulant medication and is usually prescribed for individuals with Attention-Deficit/Hyperactivity Disorder to manage ADHD behavioral symptoms
Other Names:
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Experimental: Modafinil Participants in this group will receive 100mg Modafinil and 2.5mg placebo (Methylphenidate shape) in addition to physical therapy program |
Drug: Modafinil
This medication is a Central Nervous System stimulant and is usually used to treat neurological conditions, including Narcolepsy
Other Names:
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Placebo Comparator: Placebo Participants in this group will receive 2.5mg placebo (Methylphenidate shape) and 100mg placebo (Modafinil shape) in addition to physical therapy program |
Other: Placebo
Participant will receive placebo tablets (Methylphenidate and Modafinil shape)
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children diagnosed with spastic diplegic or quadriplegic CP by a physician.
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Children aged between 7-12 years old.
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Children with CP classified as level I & II based on the gross motor function classification system (GMFCS).
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Children with CP that are receiving physical therapy for ≥ 3 months.
Exclusion Criteria:
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Children that had a seizure attack in the past 6 months
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Children that have been diagnosed with attention deficit/ hyperactivity disorder (ADHD)
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Children that had any surgery within the last 6 months
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Children that has lower-extremity contractures determined by the passive range of motion (hips, knees, and ankles)
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Children that use medications that interfere with spasticity (e.g., Baclofen)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Physical Medicine and Rehabilitation Hospital | Kuwait | Kuwait |
Sponsors and Collaborators
- Kuwait University
Investigators
- Principal Investigator: Anwar B Almutairi, PT, PhD, Kuwait University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-2157/2022