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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2027-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neurodevelopmental Disorders Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methylphenidate

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

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

This medication is a psychostimulant medication and is usually prescribed for individuals with Attention-Deficit/Hyperactivity Disorder to manage ADHD behavioral symptoms

Modafinil

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

Group Type EXPERIMENTAL

Modafinil

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participant will receive placebo tablets (Methylphenidate and Modafinil shape)

Interventions

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Methylphenidate

This medication is a psychostimulant medication and is usually prescribed for individuals with Attention-Deficit/Hyperactivity Disorder to manage ADHD behavioral symptoms

Intervention Type DRUG

Modafinil

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

Intervention Type DRUG

Placebo

Participant will receive placebo tablets (Methylphenidate and Modafinil shape)

Intervention Type OTHER

Other Intervention Names

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Ritalin Provigil Control

Eligibility Criteria

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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)

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No