AzTrials
AzTrials

Neurodevelopmental DisordersEarly Phase 1CPNCT05675098

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

A Early Phase 1 study testing Methylphenidate and Modafinil in people with Neurodevelopmental Disorders and Cerebral Palsy, run by Kuwait University at 1 site in Kuwait.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 7 to 12 years
Conditions the study is for
Neurodevelopmental Disorders, Cerebral Palsy
What is being tested?
Methylphenidate and Modafinil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteKuwait
Study dates
1 May 2023to 1 Feb 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kuwait1 site

  • Physical Medicine and Rehabilitation Hospital

    Kuwait City

    Anwar B Almutairi, PT, PhD, +96599834418, almutairi.anwar@ku.edu.kw

    Anwar B Almutairi, PT, PhD

Other trials in Kuwait

About this study

Official title: 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.

Read the 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.

Being tested
Methylphenidate, Modafinil, Placebo
Keywords
methylphenidate, Modafinil, physical therapy, motor performance, spasticity, physical function
Medical subject headings
Neurodevelopmental Disorders, Cerebral Palsy, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethylphenidateDrug

    Also called Ritalin

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

  • ModafinilDrug

    Also called Provigil

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

  • PlaceboOther

    Also called Control

    Participant will receive placebo tablets (Methylphenidate and Modafinil shape)

Study groups in NCT05675098
Study groupRoleWhat they receive
MethylphenidateExperimentalParticipants in this group will receive 2.5mg Methylphenidate and 100mg placebo (Modafinil shape) in addition to physical therapy program
Receives: Drug: Methylphenidate
ModafinilExperimentalParticipants in this group will receive 100mg Modafinil and 2.5mg placebo (Methylphenidate shape) in addition to physical therapy program
Receives: Drug: Modafinil
PlaceboPlacebo comparatorParticipants in this group will receive 2.5mg placebo (Methylphenidate shape) and 100mg placebo (Modafinil shape) in addition to physical therapy program
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gross motor function measure (GMFM)

    To determine changes in functional motor abilities.

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

  2. Modified Ashworth Scale (MAS)

    To determine changes in spasticity

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

Secondary outcomes (8)

  1. Body height

    To determine body height

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

  2. Timed up and go (TUG)

    To assess dynamic balance

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

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

    To assess the change in functional strength

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

  4. Modified clinical test for sensory interaction of balance (MCTSIB)

    To assess static balance

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

  5. Ten-meter walk test (10MWT) (normal pace)

    To assess change in gait speed

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

  6. 2-Minutes Walking Test (normal pace)

    To determine changes in fatigue

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

  7. The University of California, San Diego Shortness of Breath Questionnaire (UCSDSOBQ)

    To determine changes in respiratory function

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

  8. Body weight

    To determine body weight

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05675098
Sponsor's protocol ID
IRB-2157/2022
Acronym
CP
Status last verified
Mar 2023
First submitted
13 Dec 2022
Last updated
8 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To be determined

Publications

  • 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.

    PubMed 38441919

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Methylphenidate and Modafinil in people with Neurodevelopmental Disorders and Cerebral Palsy, run by Kuwait University at 1 site in Kuwait.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gross motor function measure (GMFM) (time frame: Baseline, 6 weeks, 12 weeks, and 24 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05675098, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
CP Clinical Trial NCT05675098 | AzTrials