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

Sponsor
Kuwait University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05675098
Collaborator
(none)
30
1
3
48
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Central Nervous System Stimulants on Physical Function in Children With Cerebral Palsy: A Pilot Randomized Controlled Trial
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methylphenidate

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

Drug: Methylphenidate
This medication is a psychostimulant medication and is usually prescribed for individuals with Attention-Deficit/Hyperactivity Disorder to manage ADHD behavioral symptoms
Other Names:
  • Ritalin
  • Experimental: Modafinil

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

    Drug: Modafinil
    This medication is a Central Nervous System stimulant and is usually used to treat neurological conditions, including Narcolepsy
    Other Names:
  • Provigil
  • Placebo Comparator: Placebo

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

    Other: Placebo
    Participant will receive placebo tablets (Methylphenidate and Modafinil shape)
    Other Names:
  • Control
  • Outcome Measures

    Primary Outcome Measures

    1. Gross motor function measure (GMFM) [Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]

      To determine changes in functional motor abilities.

    2. Modified Ashworth Scale (MAS) [Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]

      To determine changes in spasticity

    Secondary Outcome Measures

    1. Body height [Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]

      To determine body height

    2. Timed up and go (TUG) [Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]

      To assess dynamic balance

    3. Five times sit to stand test (5x Sit-To-Stand Test /5XSST) [Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]

      To assess the change in functional strength

    4. Modified clinical test for sensory interaction of balance (MCTSIB) [Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]

      To assess static balance

    5. Ten-meter walk test (10MWT) (normal pace) [Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]

      To assess change in gait speed

    6. 2-Minutes Walking Test (normal pace) [Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]

      To determine changes in fatigue

    7. The University of California, San Diego Shortness of Breath Questionnaire (UCSDSOBQ) [Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]

      To determine changes in respiratory function

    8. Body weight [Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention]

      To determine body weight

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Physical Medicine and Rehabilitation Hospital Kuwait Kuwait

    Sponsors and Collaborators

    • Kuwait University

    Investigators

    • Principal Investigator: Anwar B Almutairi, PT, PhD, Kuwait University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Anwar Amutairi, Assistant Professor, Kuwait University
    ClinicalTrials.gov Identifier:
    NCT05675098
    Other Study ID Numbers:
    • IRB-2157/2022
    First Posted:
    Jan 9, 2023
    Last Update Posted:
    Jan 9, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Dr. Anwar Amutairi, Assistant Professor, Kuwait University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 9, 2023