Research and Clinical Trials *NEW*

Asian boy in wheelchair playing with clay on a pink and purple background
Updated May 5, 2022
OVERVIEW

What are Clinical Trials?

Clinical research studies health and illnesses in people. Experts use research to study the causes of diseases, chronic conditions and symptoms, and learn more about certain treatments and if they work. Clinical trials can also look for medical approaches to prevent, detect or treat conditions and illnesses.

Clinical trials may include treatments, procedures or changes in behavior. Before these medical approaches can be approved for the public, they are tested through clinical trials.

By being part of a clinical trial, you can help improve treatments for cerebral palsy.  The more of us who participate when we have an opportunity, the more researchers will learn and be able to help!

Why do researchers do Clinical Trials?

A well-designed clinical trial is the best way to prove a treatment or medical approach works. When researchers study a new treatment, medicine or approach, they usually don’t know if it will be helpful, or will make no difference compared to other interventions. They try to determine safety and effectiveness by measuring certain outcomes in participants.

What happens during the Clinical Trial?

During the trial, researchers compare a new intervention with an existing one. Or they may compare a new medicine or treatment with a “placebo.” A placebo is a medicine or treatment that appears to be like the new medicine or treatment but has no active ingredients.

Participants get specific treatments or interventions based on a research plan. This is also called research protocol. Interventions can be a medical product (e.g., drug or device), a procedure (e.g., surgery) or changes to the participants’ behavior (e.g., diet or exercise).

Featured Clinical Trials

The Cerebral Palsy Foundation is committed to sharing the most up to date Cerebral Palsy clinical trial and research study information with you on an ongoing basis. 

Every month we'll highlight new or innovative clinical trials around the United States and the world that may be a fit for you or your family member.  Check back often for what's new and exciting in the world of cerebral palsy research.

On May 5, 2022, there are currently 258 cerebral palsy clinical trials and research studies in the United States and 1035 around the world.  Not all of these trials are actively recruiting participants at this time.  One great source of information about clinical trials is www.clinicaltrials.gov, operated by the National Institutes of Health US National Library of Medicine, where you can find clinical trials that are of interest or located near you.  It's easy to visit www.clinicaltrials.gov and enter search terms for cerebral palsy clinical trials and research studies you may be interested in learning more about.

IMPORTANT: * ClinicalTrials.gov is a resource provided by the U.S. National Library of Medicine. Listing a study on ClinicalTrials.gov does not mean it has been evaluated by the Cerebral Palsy Foundation and does not constitute medical advice.  Before participating in a study, talk to your health care provider and learn about the risks and potential benefits.

Highlighted Cerebral Palsy Clinical Trials - May 2022

Currently, there are 71 clinical trails actively recruiting participants around the United States in different geographic locations. We have highlighted a few below. You can click on each link to learn more about the trial or study, including where it is located and what medical or research institution is involved.  We've included research studies and trials focusing on both children and adults with different types of cerebral palsy.

Multi-Center and NIH Based Clinical Studies

1) Dopamine and Motor Learning in Cerebral Palsy

https://clinicaltrials.gov/ct2/show/NCT02839733

Study Description

Cerebral palsy (CP) is the most common lifelong motor disability. The neurotransmitter dopamine (DA) is important in cognition and emotions/behavior. DA may also be important in motor skill learning. Genes that relate to DA function may affect a persons ability to learn new cognitive or motor skills. Some children with CP can learn motor skills easily while others have trouble. National Institutes of Health Researchers want to find out if DA gene variations cause some of this variability.

2) Cerebral Palsy Hip Outcomes Project - International Multi-Center Study

https://clinicaltrials.gov/ct2/show/NCT01987882

Study Description

The primary purpose of the project is to evaluate the effectiveness of different intervention strategies to prevent or relieve symptoms associated with hip instability in children with severe cerebral palsy, using the validated Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD©) questionnaire as the primary outcome measure of health-related quality of life for this population.

3) Perinatal Arterial Stroke: A Multi-Site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)

https://clinicaltrials.gov/ct2/show/NCT03910075

Study Description

The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 36 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 240 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS.

4) Neonatal Seizure Registry - Developmental Functional Evaluation (NSR-DEV)

https://clinicaltrials.gov/ct2/show/NCT04337697

Study Description

Neonatal seizures due to brain injury (acute symptomatic seizures) are associated with high risk of neurodevelopmental disability in infancy. Although prognosis in early childhood is a critical question for parents and providers, outcomes beyond infancy are largely unknown. Further, parents of infants with neonatal seizures are at risk for mental health disorders, which can undermine their ability to care for a child with medical complexity and may contribute to impaired child development.

The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants enrolled at one of nine sites across the USA. Participants will be evaluated using developmental questionnaires and in-person neurodevelopmental testing. Parent well-being will be assessed at each time point.

5) Pain Burden in Children and Adolescents with Cerebral Palsy (CPPain)

Study Description

https://clinicaltrials.gov/ct2/show/NCT04219020

Pain in children and adolescents with cerebral palsy (CP) is a significant health challenge that so far has received too little attention. We lack knowledge on how pain is experienced, its consequences and of perceived support in managing pain. The overarching aim of the CPPain-program is to reduce pain experience, pain interference (e.g. pain burden) in children and adolescents living with CP. CPPain has a prospective cohort comparative design and will include before- and after measurements and process evaluation of a nested intervention.

This protocol concerns qualitative and quantitative data collection for the baseline of the CPPain program. The aim of the baseline data collection is to contribute in-depth knowledge of the pain burden in children and adolescents with CP. This knowledge is required to develop targeted pain-diminishing interventions in this vulnerable group of children with a high burden of challenges related to their chronic disease. In the next step, nested intervention will be co-created with children and adolescents with CP, their parents as well as health care professionals, and other professional caregivers involved in or responsible for management of pain based on existing research and baseline findings.

North/Northeastern States (ME,VT, NH, MA, RI, CT, NJ, NY, PA, OH, IN, MI)

1) Amantadine in Treating Cognitive and Motor Impairments in Adolescents and Adults with Cerebral Palsy

https://www.clinicaltrials.gov/ct2/show/NCT04273737

Study Description

Cerebral palsy (CP) is a common childhood-onset disability associated with motor and cognitive impairments, however most research is focused on motor outcomes. The aim of this study is to determine the effects of Amantadine, a dopaminergic agonist, on cognitive function in adolescents and adults with CP.

2) Immersive Virtual Reality for Visuo Motor Skill Assessment in Children with Hemiplegia

https://clinicaltrials.gov/ct2/show/NCT04612049

Study Description

A significant deficit affecting nearly half of children with hemiplegia is visual-motor integration, or eye-hand coordination. Children have difficulties integrating visual and motor information to effectively plan and execute movements. Visual-motor impairments are detrimental because they affect accuracy of reaching and grasping, which are movements involved in feeding, writing, and sports participation, among many other daily life activities. Although paper-and-pencil and touchscreen computer assessments exist, these fail to evaluate impairments under realistic, 3D conditions. This assessment barrier leads to significant gaps in knowledge the influence of these impairments on children's performance of functional activities.

The purpose of this study is to evaluate low-cost HMD-VR as a realistic assessment tool for visual-motor integration deficits in children with hemiplegia. The long-term goals of our research program are to: 1) Inform clinical decision-making practices by providing families and clinicians with precise, accurate information about children's abilities; and 2) Generate new knowledge about visual-motor integration impairments to enhance the effectiveness of both virtual and conventional rehabilitation interventions.

3) Home Based Tele-Exercise for People with Chronic Neurological Impairments

https://clinicaltrials.gov/ct2/show/NCT04564495

Study Description

This study aims to examine how effective seated Zoom exercise classes are for a person with CNI for addressing cardiovascular health, physical wellness and quality of life. If these classes prove to be effective, online platforms could be a viable avenue for those with CNI to exercise and increase/maintain wellness without having to leave their homes. The investigators are also attempting to determine if a class with a live instructor vs a pre-recorded class has an effect on motivation, compliance, exertion and modifications/safety.

The entire process, including screening and consenting, will be done via Zoom and Redcap, potentially providing a blueprint for the future studies. This process can enable participants to participate in studies with minimal inconvenience, expense and effort of traveling for the consent process.

4) The Impact of Dosing Parameters on Motor Skill Acquisition and Retention in Bilateral Cerebral Palsy

https://clinicaltrials.gov/ct2/show/NCT03940989

Study Description

A recent systematic review found that therapeutic interventions that apply principles of motor learning with intense practice improve functional upper extremity movement in children with unilateral CP.  Evidence of efficacy for any treatment approach aimed at improving motor function in bilateral CP (the most prevalent form) is lacking. Preliminary investigation suggests that intensive (90 hours) goal-directed, task-specific training provided in a 3-week day camp format can improve functional movement of both the upper (UE) and lower extremity (LE) and postural control in children with Bilateral CP. To date, HABIT-ILE has only been provided in a day camp setting over several weeks. Implementing the dosing schedule of this promising intensive approach in a hospital setting requires innovative resource allocation (space and staff); thus, examining alternative delivery models is imperative. The purpose of this study is to conduct a multi-center randomized control trial (RCT) to determine whether 90 hours of HABIT-ILE improves functional motor skills, activity and motivation in children with CP when dosed in a camp format at 6-hours/day, 5 days/week for three weeks and 6-hours/day, one day/week for 15 weeks.

5) Real World Testing of Brain-Computer Interface

https://www.clinicaltrials.gov/ct2/show/NCT04026581

Study Description

The goal of this project is to test a new AAC-BCI device comparing gel and dry electrode headgear used for communication while providing clinical care. Innovative resources will be employed to support the standard of care without considering limitations based on service billing codes. Clinical services will include AAC assessment, AAC-BCI device and treatment to individuals with minimal movement due to amyotrophic lateral sclerosis (ALS), brain stem strokes, severe cerebral palsy, traumatic brain injury (TBI) and their family support person. This is a descriptive study designed to measure and monitor the communication performance of individuals using the AAC-BCI, any other AAC strategies, their user satisfaction and perceptions of communication effectiveness, and the satisfaction of the family support persons.

South/Southeastern States (VA, WV, KY, DE, MD, TN, AL, NC, SC, GA, FL)

1. Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study in Adults

https://clinicaltrials.gov/ct2/show/NCT03797378

Study Description

The purpose of this study is to test the effects of an innovative exercise program referred to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants with physical/mobility disabilities will be recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The primary aim of this study is to determine the effects of a 12-week M2M program on health and fitness in participants with physical/mobility disabilities who are in one of three functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II - able to exercise sitting and standing with/without support, and 3) Group III - able to exercise one side of the body more than the other side. The second aim is to compare the observed effects of the program in this study to a previous M2M study that groups participants based on disability type. The third aim of this study is to test whether adherence (defined as attendance to the 12-week program) affects the effects of M2M in participants with physical/mobility disabilities. The potential influences of different functional mobility and disabilities of participants on how the program affects participants' health and fitness outcomes will also be tested.

2) Short-Burst Interval Treadmill Training Cerebral Palsy

https://clinicaltrials.gov/ct2/show/NCT04026295

Study Description

Ambulatory children with cerebral palsy (CP) walk predominately in low intensity stride rates with little variability, thus limiting walking activity and ability to participate in daily life. In contrast, typically developing (TD) children engage in short bursts of intense walking activity interspersed with varying intervals of low intensity walking within daily life.  The proposed research will be the first step in a continuum of research that is expected to direct locomotor training protocols and rehab strategies across pediatric disabilities and positively affecting walking performance and mobility for children with CP.

3) I-C-Fun In Children with Cerebral Palsy

https://www.clinicaltrials.gov/ct2/show/NCT04598711

Study Description

The overall goal of this research is to use ischemic conditioning to enhance muscle power, motor leaning, and mobility in children with CP. Our previous work demonstrated that when paired with strength training, RLIC improved muscle strength and activation in healthy, young adults and motor learning in healthy older adults. The current study extends that work to determine if RLIC enhances muscle power, dynamic balance, and walking performance in children with CP. This Phase II study will yield the necessary information to design and execute subsequent randomized controlled trials in children with CP as well as other neurological conditions.

Central/Northern Central States (WI, MN, IA, IL, MO, AR, LA, TX, OK, KS, NE, SD, ND)

1) Perinatal Stroke: Brain Reorganization During Infancy

Study Description

This study will be a longitudinal multiple-visit observational study, done to identify possible bioindicators of recovery and repair of motor corticospinal pathways which may be targeted by future interventions in infants with perinatal stroke.

The first two years of life constitute a critical period of brain development and heightened neuroplasticity. There is now a consensus that, due to brain plasticity and rapid development, providing an early intervention may result in optimal recovery and lower costs of care. Unfortunately, researchers still have only limited understanding of how the brain develops after perinatal stroke and as a result CP diagnoses are typically not made until two years of age. There is an urgent need for very early diagnosis, prognosis and understanding of mechanisms in order to develop novel early interventions to improve outcomes in perinatal stroke with resultant CP.

Integrating study team's experience in studying and caring for this vulnerable infant stroke population, they propose to use non-invasive brain stimulation, neuroimaging, and behavioral assessments to analyze associations between development patterns, especially in the CST, and potential diagnosis of CP.

50 participants will be recruited and complete 1 visit at time point 1 (0-2 months), and 2 visits at each timepoints 2-5 with windows of +- 4 weeks (3-6 months, 12 months, 18 months and 24 months). Visits will consist of Magnetic Resonance Imaging (MRI) assessment during the child's natural sleep, Transcranial Magnetic Stimulation (TMS), and Motor Behavioral Assessments.

For more information visit the Brain Recovery Study: https://pnl.waisman.wisc.edu/research/

or  https://clinicaltrials.gov/ct2/show/NCT05013736

2) COMET- C: Community Outreach Model of Education and Training on Communication - Focus Group

Study Description

Researchers at the Shirley Ryan Ability Lab are seeking adults with cerebral palsy, and other disabilities, who are over the age of 21 and have communication difficulties, to share your experiences interacting with businesses/service providers during a two hour focus group. The goal of the research study is to learn about participants' experiences when they communicate with businesses / service providers.

For more information please call the Center for Aphasia research at 312-238-6163 or email Elissa Larkin, elarkin@sralab.org.

3) Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy

https://clinicaltrials.gov/ct2/show/NCT04957277

Study Description

The purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy during stepping tasks.

Individuals with bilateral cerebral palsy (BCP) sustain a neonatal brain injury that leads to altered control to the lower limbs. This can make stepping up or down a curb or stair challenging and is especially important as performance in stair-climbing is associated with limitations to overall mobility and community participation in cerebral palsy.

Participants who consent to the study will be instructed to perform multiple step-ups and step-downs on a single raised platform. The parameters of the stepping task may change by adding weight to the body or subtracting weight from the body.

3) Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker

https://clinicaltrials.gov/ct2/show/NCT03937700

Study Description

This trial is being conducted to determine if the CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy. Participants will engage in an 8-week training program, consisting of 2-3 sessions per week based on the level of gait impairment. Percentage range of motion (ROM), partial body weight support (PWBS), and gait velocity are the principal parameters under variation during training. Additionally, screening, baseline and post-training testing sessions will be conducted

Western States (NM, CO, WY, MT, ID, UT, AZ, NV, OR, WA, CA)

Western Multi-State

1) Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children with Cerebral Palsy (START-PLAY-CP)

https://clinicaltrials.gov/ct2/show/NCT04230278

Study Description

The purpose of the proposed project is to compare the efficacy of two fully developed physical therapy interventions in 8-24 months olds with or at high risk of having Cerebral Palsy (CP). Sitting Together And Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and preventing impairments. The project builds on a nearly complete clinical trial evaluating the efficacy of the START-Play intervention compared to a non-dose matched comparison group. The proposed study directly addressed the need for a dose-matched clinical trial to consider the impact of dose of intervention on efficacy. A direct comparison of START-Play with the dose matched (24 visits in 3 months) UCPT provided in the same environment (homes) and provided by licensed physical therapists will allow for a direct comparison of the efficacy of interventions based on two different set of key principles.