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

December 21, 2022 updated by: Dr. Anwar Amutairi, Kuwait University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kuwait
      • Kuwait, Kuwait
        • Physical Medicine and Rehabilitation Hospital
        • Contact:
        • Principal Investigator:
          • Anwar B Almutairi, PT, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross motor function measure (GMFM)
Time Frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
To determine changes in functional motor abilities.
Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
Modified Ashworth Scale (MAS)
Time Frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention
To determine changes in spasticity
Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuwait University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

February 1, 2027

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Estimate)

January 9, 2023

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2157/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

To be determined

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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