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

NCT05675098 | Not Yet Recruiting Early Phase 1

• 1 other identifier: IRB-2157/2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders; Cerebral Palsy

Keywords

methylphenidate; Modafinil; physical therapy; motor performance; spasticity; physical function

Outcome Measures

Primary Outcomes (2)

• Gross motor function measure (GMFM)

  To determine changes in functional motor abilities.

  Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention

• Modified Ashworth Scale (MAS)

  To determine changes in spasticity

  Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention

Secondary Outcomes (8)

• Body height

  Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention

• Timed up and go (TUG)

  Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention

• Five times sit to stand test (5x Sit-To-Stand Test /5XSST)

  Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention

• Modified clinical test for sensory interaction of balance (MCTSIB)

  Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention

• Ten-meter walk test (10MWT) (normal pace)

  Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention

Study Arms (3)

Methylphenidate

EXPERIMENTAL

Participants in this group will receive 2.5mg Methylphenidate and 100mg placebo (Modafinil shape) in addition to physical therapy program

Drug: Methylphenidate

Modafinil

EXPERIMENTAL

Participants in this group will receive 100mg Modafinil and 2.5mg placebo (Methylphenidate shape) in addition to physical therapy program

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Participants in this group will receive 2.5mg placebo (Methylphenidate shape) and 100mg placebo (Modafinil shape) in addition to physical therapy program

Other: Placebo

Interventions

Methylphenidate DRUG

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

Methylphenidate

Modafinil DRUG

This medication is a Central Nervous System stimulant and is usually used to treat neurological conditions, including Narcolepsy

Also known as: Provigil

Modafinil

Placebo OTHER

Participant will receive placebo tablets (Methylphenidate and Modafinil shape)

Also known as: Control

Placebo

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kuwait University: lead

Study Sites (1)

Physical Medicine and Rehabilitation Hospital

Kuwait City, Kuwait

Location

Related Publications (1)

• Alotaibi M, Almutairi AB, Alhirsan S, Alkazemi A, Alharbi M, Alrashdi N, Taqi A, Alamiri B, Vogtle L, Alqahtani MM. Psychostimulant Medications for Physical Function and Spasticity in Children With Cerebral Palsy: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 5;13:e53728. doi: 10.2196/53728.

  PMID: 38441919 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders; Cerebral Palsy; Muscle Spasticity

Interventions

Methylphenidate; Modafinil

Condition Hierarchy (Ancestors)

Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Anwar B Almutairi, PT, PhD

  Kuwait University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 9, 2023
• Study Start: May 1, 2023
• Primary Completion: February 1, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)