Clinical trial NCT05675098: Central Nervous System Stimulants and Physical Function in Children With Cerebral Palsy
Official title: Effect of Central Nervous System Stimulants on Physical Function in Children With Cerebral Palsy: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Neurodevelopmental Disorders
Cerebral Palsy
Keywords: methylphenidate
Modafinil
physical therapy
motor performance
spasticity
physical function
Lead sponsor: Kuwait University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Gross motor function measure (GMFM)
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Secondary outcomes:
measure: Body height
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
measure: Timed up and go (TUG)
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
measure: Five times sit to stand test (5x Sit-To-Stand Test /5XSST)
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
measure: Modified clinical test for sensory interaction of balance (MCTSIB)
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
measure: Ten-meter walk test (10MWT) (normal pace)
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
measure: 2-Minutes Walking Test (normal pace)
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
measure: The University of California, San Diego Shortness of Breath Questionnaire (UCSDSOBQ)
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
measure: Body weight
timeFrame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Physical Medicine and Rehabilitation Hospital
Study officials:
affiliation: Kuwait University
name: Anwar B Almutairi, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: