Adult Recruiting Studies

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. 

Currently there are 60 studies recruiting adults in the United States. Below we have highlighted a few diverse studies that have different areas of research focus. To search the full list of studies, visit clinicaltrials.gov . Each month we will highlight a few studies that may covering different topics of interest. 

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.

1) Operant conditioning of the soleas stretch reflex

Study Description

Individuals with CP face significant challenges due to spasticity that causes activity and participation restrictions with increase in secondary conditions. This is caused by injury to the upper motor neurons causing disruption to the neural circuitry responsible for maintaining motor tone. A novel intervention, OC of the H reflex has shown promising effects to reduce spasticity and improve motor function in people with stroke and spinal cord. Its many known benefits include easy administration, non-invasive technique, no side effects, and long-term retention. In the study, the investigators will attempt to decrease the increased muscle tone of individuals with CP. 

https://clinicaltrials.gov/ct2/show/NCT05571033

Eligibility:

• Age 18 and Above
• Diagnosis of spastic U/L Cerebral Palsy
• Gross Motor Function Classification System level I-III
• Stable medical background
• Current medication will remain unchanged for 3 months
• Provides informed consent
• Can walk at least 10 meters with or without assistive device
• Meets minimum study procedure requirements (elicitation of H-reflex).

Contacts: Devina Kumar, PhD914-368-3160, dek4004@med.cornell.edu, Kathleen Friel, PhD    914-368-3116,  kaf3001@med.cornell.edu  

2) Telehealth Virtual Reality Gaming on Cardiometabolic Health Among Youth With Cerebral Palsy

Study Description

VR gaming delivered via telehealth may be an optimal method of promoting sustainable exercise behavior among large groups of youth. Home-based telehealth programs that incorporate 'virtual' behavioral coaching (tele-coaching) are a desirable approach for promoting non-supervised, exercise behavior among people with disabilities who do not have convenient access to community programs.

The primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group. The secondary purpose is to understand behavioral mechanisms that explain participation in exergaming through semi-structured interviews with participants from both groups at post-intervention or dropout. 

https://clinicaltrials.gov/ct2/show/NCT05336227

Eligibility:

• Age 13-24
• medical diagnosis of cerebral palsy
• physician clearance to participate
• access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer
• a caregiver to support the child

Contacts: Raven Young (205) 638-6445,   ravensamuel@uabmc.edu  and Byron Lai, PhD  (205) 638 - 9790 ext 8-9725, blai@uabmc.edu    

3) Pain and Anatomical Correlation on MRI 

Study Description

The investigators hope to use MRI biomarkers to identify and characterize sensorimotor network disruption patterns associated with chronic pain and sensory deficits in CP. Investigators will use existing information in the medical record as well as subjective reports from interview, physical exam data, and anatomical and functional MRI data to non-invasively identify brain and spine injury correlates of pain and sensory deficits.

https://www.clinicaltrials.gov/ct2/show/NCT05197946

Eligibility:

• Individuals with CP 8 years and older

Contacts: Collen Lenz, MS  (443) 923-2706  CPpainStudy@kennedykrieger.org  and  Nicole Gorny, MS  (443) 923-9272  CPpainStudy@kennedykrieger.org

4) Transcutaneous Stimulation for Neurological Populations

Study Description

The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal stimulation has been used extensively for individuals with spinal cord injury, and has demonstrated improvements in function. This study will extend this work to other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar impairments as spinal cord injury.

https://www.clinicaltrials.gov/ct2/show/NCT04467437

Eligibility:

• Individuals 10 to 70 years old with a neurologic condition
• Can walk 20 yards, with or without an assistive device, and have a stable medical condition
• Are capable of performing simple cued motor tasks and who can follow 2-3 step commands
• Have ability to attend up to 5 sessions per week physical therapy sessions and testing activities
• Have adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period.
• Can read and speak English

Contacts: Siddhi R Shrivastav, BPTh, MS  973-444-1940  siddhis@uw.edu  and  Chet T Moritz, PhD  206-221-2842  ctmoritz@uw.edu

5) Cognitive Behavioral Therapy for Adults with CP

Study Description:

The purpose of the study is to understand if cognitive behavioral therapy can improve pain-related thought patterns and pain-related impairment in adults with cerebral palsy. To investigate the efficacy of CBT-CP on reducing pain-related impairment and catastrophizing thought patterns in communicative adults with cerebral palsy, investigators will conduct and compare evaluations before and after participants receive a combination of CBT-CP and pain education. CBT-CP involves weekly group-therapy sessions for 12 weeks. Pain education is comprised of 12 weeks of usual medical care in addition to being given an educational booklet on chronic pain.

https://clinicaltrials.gov/study/NCT06269926

Eligibility: Adults with CP who experience pain

Contact: Paul Salib, B.S, (443) 923-9272, salib@kennedykrieger.org
 

6) Impact of Community Based Wellness Programs on the Triple Aim

Study Description

People with disabilities experience a staggering incidence of secondary conditions that can result in death or negatively impact their health, participation in the community, and quality of life. Many of these chronic secondary conditions are preventable. The Institute for Healthcare Improvement has advocated for optimizing care through programs that simultaneously improve health and the patient experience of care, while reducing cost, called the "Triple Aim."  In order to identify potential models of healthcare delivery for individuals with disabilities that are effective in achieving the Triple Aim, we will conduct a rigorous research project to evaluate the impact of two different models of care on the Triple Aim: 1) a community-based care management program delivered by a non-profit organization through waiver funds, and 2) the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with disabilities between ages 55-64.

https://www.clinicaltrials.gov/ct2/show/NCT02938130

Eligibility:

• 7 years and older
• Individuals who are eligible for the Community Partners program
• Individuals who are eligible for the Community LIFE program between the age of 55-64

Contacts: Zara Ambadar, PhD  412-608-6118  ambadar@pitt.edu

7) Mobile Health Self-Management

Study Description

This study will assess the benefits of using mobile health system designed for individuals with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and self-management skills compared to those who receive standard of care only.

https://www.clinicaltrials.gov/ct2/show/NCT02592291

Eligibility:

• 12 years or older with a diagnosis of a chronic and complex condition such as Spina Bifida, Spinal Cord Injury, Cerebral Palsy and Traumatic Brain Injury, etc.
• Live in a community setting (not within a residential facility that provides care to them)
• Pass all the functional screening tests which include basic usage of a smart phone, and impairment severity assessments

Contacts: Zara Ambadar, PhD  412-608-6118 ambadarz@upmc.edu

8) Peripheral Modulation of Muscle Stiffness and Spasticity

Study Description

This is a trial of human recombinant hyaluronidase injections in individuals with post-stroke upper limb muscle stiffness. The investigators will recruit 50 individuals, 25 males and 25 females, who will be randomized to receive either hyaluronidase plus saline or normal saline injections (first injection) in Phase 1 of the study over 5 visits. Then participants will cross over to Phase 2 to receive a second injection, where the treatment arm will receive the placebo and the placebo arm will receive the treatment. This design will ensure that all participants receive the drug treatment, which will facilitate recruitment.  

https://www.clinicaltrials.gov/ct2/show/NCT03306615

Eligibility:

• 18 years and older
• Ischemic or hemorrhagic stroke 6-120 months prior
• Moderately-severe muscle stiffness, score of 2-3
• Lack of full passive and active range of motion in at least 2/4 areas (shoulder, elbow, forearm, wrist) in the hemiparetic upper limb;
• Willingness to have MRI, complete all clinical assessments, and comply with study protocols;
• Ability to give informed consent and HIPPA certifications; and

Contacts: Maria Fernanda Pena Prieto, MD  410-955-1347  mpenapr1@jhu.edu  and  Matthew Bird, MA  410-955-1381  mbird6@jhmi.edu

9) Sensorimotor Control During Postural Transitions in CP

Study Description

The purpose of this study is to investigate whether a light electrical stimulation to leg muscles and joints can help people with Cerebral Palsy (CP) maintain balance during everyday tasks such as getting up from a chair and walking. Children and young adults with CP can have trouble with daily tasks such as standing up, sitting down on the chair and turning. The difficulty in maintaining balance sometimes lead to falls. This raises risk of disability in CP as children age into teens and adults. Current treatments are not very effective. In this study, children and young adults will be asked to stand up from a stool, walk in a straight line, turn, walk back and sit down on the stool. Participants will receive electrical stimulation at a very low intensity that cannot be felt to help increase their sensory perception. The investigators will evaluate treatment by testing balance, and other functional measures.

https://www.clinicaltrials.gov/ct2/show/NCT05384990

Eligibility:

• Ages 8-24 with a diagnosis of CP and GMFCS level I-II
• Ability to stand up from a chair and start walking.
• Migration index of proximal hip (MIGR) < 40% femoral head covering in acetabulum
• At least 0° passive dorsiflexion range of motion (ROM)
• Sufficient visuoperceptual, cognitive and communication skills
• Seizure-free or well-controlled seizures
• No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability
• Ability to communicate pain or discomfort
• Ability to assent/consent or obtain parent/guardian consent

Contacts: Samuel CK Lee, PT, PhD  302-831-2450  slee@gmail.com  and Khushboo Verma, PT  302-831-7611  vkhush@udel.edu

10) Cerebellar Deep Brain Stimulation for Movement Disorders in Cerebral Palsy in Children and Young Adults

Study Description:

The purpose of the study is to test the safety of placing Deep Brain Stimulators (DBS) in a part of the brain called the cerebellum and using electrical stimulation of that part of the brain to treat movement symptoms related to cerebral palsy. All participants will receive deep brain stimulation (DBS) in the cerebellum. For the first 20 weeks, every participant undergoes an open label phase to titrate stimulation and determine optimal stimulation settings. Following that phase, each participant starts three cycles of randomized, paired 8-week exposure periods, each pair including effective stimulation followed by sham stimulation, or vice versa. Effective stimulation will be the optimal stimulation settings determined during the open label phase.

https://clinicaltrials.gov/study/NCT06122675

Eligibility: 

• 7 - 25 years
• Dystonic and/or choreoathetotic cerebral palsy with or without spasticity
• Clear history of hypoxic ischemic brain injury preceding motor symptoms made by a pediatric neurologist, with supporting MRI findings. See study listing for full criteria.

Contact: Marta San Luciano Palenzuela, MD, MS, 415-353-2311,

11) Testing an Adjustable Ankle Orthosis During Walking in CP

Study Description: 
This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.

https://clinicaltrials.gov/study/NCT06262191

Eligibility:

• 8 years to 35 years
• Ambulatory CP
• Can walk on a treadmill for 6 minutes
• Wear physician prescribed AFO's

Contact: Zach Lerner, PhD, 928-523-9787, zachary.lerner@nau.edu

12) Cerebral Palsy and the Study of Brain Activity During Motor Tasks

Study Description

Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS) and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it is active. EEG records electrical activity in the brain. Both have been used safely for many years, even in very young children. NIRS or EEG can be used while a person is moving to show which parts of the brain are the most active. Researchers want to use NIRS and EEG to study brain activity during movement in people with cerebral palsy and healthy volunteers. Learning more about how people with and without cerebral palsy use their brain to control their muscles may lead to new ways of training people with cerebral palsy to move better.

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

Eligibility:

• Individuals at least 5 years and up of age who have cerebral palsy
• Healthy volunteers at least 5 years of age.

Contacts: Functional & Applied Biomechanics  (301) 412-5989  ccrmdfab@mail.nih.gov  Diane L Damiano, PhD  (301) 451-7544  damianod@cc.nih.gov

13) Transcutaneous Stimulation for Neurological Populations

Study Description:

The purpose of this study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions.  After an initial baseline period of up to 4 weeks, participants attend up to 5 sessions per week of physical therapy sessions and testing activities, with either either intensive training only (Condition A) or intensive training combined with spinal stimulation (Condition B) for the duration of up to 11 months within the study period.

https://clinicaltrials.gov/ct2/show/NCT04467437

Eligibility:

• 10 - 70 years
• Ambulatory CP
• Can walk with and without assistance;
   

Contact: Siddhi R Shrivastav, BPTh, MS, 973-444-1940, siddhis@uw.edu, Chet T Moritz, PhD, 206-221-2842, ctmoritz@uw.edu