Research and Clinical Trials *NEW*

Asian boy in wheelchair playing with clay on a pink and purple background
Updated October 2021
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).

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 October 4, 2021, there are currently 233 cerebral palsy clinical trials and research studies in the United States and 944 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 - October 2021

Currently, there are 62 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.

1. Effect of Vibration on Muscle Properties, Physical Activity and Balance in Children with Cerebral Palsy

https://clinicaltrials.gov/ct2/show/NCT03484078

Study Description

The aim of the 6-month randomized controlled trial, with 6-month no treatment follow-up, is to examine the effects of low-magnitude vibration on muscle, physical activity, and balance in children with spastic cerebral palsy. Children with CP will be tested at five time points: baseline, 1 and 6 months after standing on a vibration platform daily 10 minutes per day, 1 and 6 months post treatment (7 months and 12 months from baseline, respectively). The findings from the proposed study will help us determine if vibration shows promise as a treatment for the impaired mobility, lower physical activity and higher risk of chronic disease in individuals with CP.

2. TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (RECLAIM-DCP)

https://clinicaltrials.gov/ct2/show/NCT03813238

Study Description

Currently, there is no approved treatment available for Dyskinesia in cerebral palsy (DCP). The available treatment options address some of the manifestations of DCP. The study population will include pediatric and adolescent participants (6 through 18 years of age) with DCP with predominant choreiform movement disorder, who have had nonprogressive CP symptoms since infancy (2 years of age). Diagnosis of DCP is based on the Surveillance of Cerebral Palsy in Europe criteria.

This is a Phase 3 study that will evaluate the efficacy and safety of TEV-50717 administered as oral tablets at a starting dose of 6 mg once daily in participants (age 6 through 18 years, inclusive) with DCP with predominant choreiform movement disorder.

 

3. 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.

4. 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.

5. 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

6. Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy (START-Play-CP)

https://www.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.

7. 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.

8. 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.

 

9. 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.

10. tDCS and Robotic Training in Adults with Cerebral Palsy

https://clinicaltrials.gov/ct2/show/NCT03038269

Study Description

The purpose of this study is to improve arm function in adults with hemiplegic cerebral palsy. Participants will receive transcranial direct current stimulation (or sham) in combination with upper extremity robotic therapy.

11. 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.

12. Functional Strength Training and Virtual Reality in Children With CP

https://clinicaltrials.gov/ct2/show/NCT04147468

Study Description

Virtual reality (VR) has shown to be effective to improve arm function in children with cerebral palsy (CP). Recently, functional strength training (FST) starts to show to improve arm function in patients with stroke but has not been extensively explored in children with CP. This pilot study is to examine the effect of FST and VR on improving arm function in children with CP as well as the neuroplasticity changes in the brain related to the level of improvement.

13. Evaluating Wearable Robotic Assistance on Gait

https://clinicaltrials.gov/ct2/show/NCT04119063

Study Description

The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).

14. 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.

15. Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention (TimeSPEEDI2)

https://clinicaltrials.gov/ct2/show/NCT03518736

Study Description

Infants born very preterm (28 weeks of gestation) are at high risk of having developmental disabilities including cerebral palsy, coordination impairments, attention deficit and learning disabilities. 

Targeted intervention supporting postural control and motor learning in the NICU have resulted in short term motor gains. Interventions that enhance parent's ability to read their infant's cues and provide engagement opportunities improve maternal mental health and infant social and cognitive outcomes in the short-term. The purpose of this randomized clinical trial is to evaluate the efficacy of an intervention that combines evidence based motor intervention and parent engagement to enhance the parent's ability to provide daily motor and cognitive opportunities resulting in improved motor and cognitive outcomes.

16. Cerebral Palsy and the Study of the Brain During Motor Tasks

https://clinicaltrials.gov/ct2/show/NCT01829724

Study Description

Objective Neural imaging during functional tasks has become more portable and accessible than magnetic resonance imaging (MRI) by utilizing non-invasive near-infrared spectroscopy (NIRS) as a means to isolate areas of brain activity by measuring blood flow dynamics and electroencephalography (EEG) to measure electrical activity on the cortical surface. Although use of these technologies for assessing cortical activation patterns is increasing, validation of these approaches, particularly in children with brain injuries such as cerebral palsy is in the early stages with few reports in the literature. The use of these in motor training paradigms for rehabilitation populations has not yet been reported. The objectives of this protocol are to: 1) systematically compare cortical activation patterns associated with specified motor and sensory tasks in healthy children and adults to those with unilateral or bilateral childhood-onset brain injury 2) extend the use of EEG in our laboratory across subject groups and tasks, when used alone or with NIRS; and 3) pilot the use of NIRS and/ or EEG as a brain biofeedback device in children with childhood-onset brain or peripheral injuries.

 

17. 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.