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

Cerebral Palsy Clinical Trial

— CP  

Official title:

Effect of Central Nervous System Stimulants on Physical Function in Children With Cerebral Palsy: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05675098
• Other study ID #: IRB-2157/2022
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 1, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: March 2023
• Source: Kuwait University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy
• Neurodevelopmental Disorders

Intervention

Drug:
• Methylphenidate
This medication is a psychostimulant medication and is usually prescribed for individuals with Attention-Deficit/Hyperactivity Disorder to manage ADHD behavioral symptoms
• Modafinil
This medication is a Central Nervous System stimulant and is usually used to treat neurological conditions, including Narcolepsy

Other:
• Placebo
Participant will receive placebo tablets (Methylphenidate and Modafinil shape)

Locations

Country	Name	City	State
Kuwait	Physical Medicine and Rehabilitation Hospital	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Kuwait University

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross motor function measure (GMFM)	To determine changes in functional motor abilities.	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Primary	Modified Ashworth Scale (MAS)	To determine changes in spasticity	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Secondary	Body height	To determine body height	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Secondary	Timed up and go (TUG)	To assess dynamic balance	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Secondary	Five times sit to stand test (5x Sit-To-Stand Test /5XSST)	To assess the change in functional strength	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Secondary	Modified clinical test for sensory interaction of balance (MCTSIB)	To assess static balance	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Secondary	Ten-meter walk test (10MWT) (normal pace)	To assess change in gait speed	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Secondary	2-Minutes Walking Test (normal pace)	To determine changes in fatigue	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Secondary	The University of California, San Diego Shortness of Breath Questionnaire (UCSDSOBQ)	To determine changes in respiratory function	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Secondary	Body weight	To determine body weight	Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention