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

• Status: Not yet recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuwait University
• Treatments: Methylphenidate; Modafinil

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)