An Early Phase 1 interventional study of Methylphenidate and Modafinil in Neurodevelopmental Disorders and Cerebral Palsy, sponsored by Kuwait University. Not yet recruiting at 1 site in Kuwait. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by Kuwait University · Early Phase 1, Interventional, and Treatment
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.
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.
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's planned enrollment of 30 is below the median of 88 across 217 interventional studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →Kuwait University is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants in this group will receive 2.5mg Methylphenidate and 100mg placebo (Modafinil shape) in addition to physical therapy program
Drug: Methylphenidate
Participants in this group will receive 100mg Modafinil and 2.5mg placebo (Methylphenidate shape) in addition to physical therapy program
Drug: Modafinil
Participants in this group will receive 2.5mg placebo (Methylphenidate shape) and 100mg placebo (Modafinil shape) in addition to physical therapy program
Other: Placebo
This medication is a psychostimulant medication and is usually prescribed for individuals with Attention-Deficit/Hyperactivity Disorder to manage ADHD behavioral symptoms
Also known as: Ritalin
This medication is a Central Nervous System stimulant and is usually used to treat neurological conditions, including Narcolepsy
Also known as: Provigil
Participant will receive placebo tablets (Methylphenidate and Modafinil shape)
Also known as: Control
Gross motor function measure (GMFM)
To determine changes in functional motor abilities.
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Modified Ashworth Scale (MAS)
To determine changes in spasticity
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Body height
To determine body height
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Timed up and go (TUG)
To assess dynamic balance
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Five times sit to stand test (5x Sit-To-Stand Test /5XSST)
To assess the change in functional strength
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Modified clinical test for sensory interaction of balance (MCTSIB)
To assess static balance
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Ten-meter walk test (10MWT) (normal pace)
To assess change in gait speed
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
2-Minutes Walking Test (normal pace)
To determine changes in fatigue
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
The University of California, San Diego Shortness of Breath Questionnaire (UCSDSOBQ)
To determine changes in respiratory function
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Body weight
To determine body weight
Time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Plan to share: No — To be determined
No publications or documents are linked to this record.
Start is estimated for May 2023; primary completion for Feb 2025, 21 months later.
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This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Methylphenidate · Modafinil
Neurodevelopmental Disorders →
Kuwait University