Clinical Studies

Below is a list of the current clinical studies conducted by Columbia Faculty involved with the Weinberg Family Cerebral Palsy Center.

For more details, please visit RecruitMe or contact cpresearch@cumc.columbia.edu

Investigating Brain Changes in People with Cerebral Palsy

Principal Investigator:  Jason Brant Carmel, MD, PhD

A key part of the CP definition is that is a non-progressive brain injury. However, as people with CP age, their function often deteriorates. This study seeks to determine whether changes in the brain structure may result in function changes, as they do in other types of brain injuries.

Cerebral Palsy Patient Registry

Principal Investigator: Jason Brant Carmel, MD, PhD

The Weinberg Family Cerebral Palsy Center's (WFCPC) research team maintains a cerebral palsy (CP) patient registry of more than 1,000 enrolled patients. This registry contains information collected from children and adults with CP. The goal of the registry is to help us learn more about CP and neuromuscular diseases, to understand the quality of life of patients with these diseases, and to study different treatment and surgical options. The registry allows our researchers to capture a more complete picture than ever of the full scope of patients living with CP and to investigate long-term care. With 10 to 15 years of data, it is now possible to study cerebral palsy across the lifespan.

Pilot Study to Evaluate the Safety and Tolerability of Spinal Cord Stimulation and Paired Spine and Brain Stimulation For Movement Recovery After Spinal Cord Injury

 

Overview

Movement requires communication between the brain and spinal cord, but this can be disrupted after a spinal cord injury (SCI). Many people with cervical SCI still have some remaining nerve pathways, which could be recruited to restore movement. While epidural spinal cord stimulation (SCS) has been used successfully to help people regain walking, its use for arm and hand function is largely unexplored.

We have partnered with the Bronx VA and City College of New York (CCNY) to study how epidural spinal cord stimulation (SCS) can help people with cervical spinal cord injury (SCI) improve arm and hand movement. Through this collaboration, participants will have temporary electrodes placed near the spinal cord. During the study, we will optimize stimulation settings, record baseline brain and spinal cord activity, and provide structured rehabilitation with occupational therapy (OT). Participants will receive daily sessions of SCS paired with OT, with clinical and physiology assessments conducted before, during, and after therapy.

Study Goals

  • Determine how epidural spinal cord stimulation (SCS) can improve arm and hand movement after cervical spinal cord injury.
  • Understand how SCS interacts with the brain and spinal cord to restore motor function.
  • Combine SCS with occupational therapy (OT) to identify effective strategies for rehabilitation.
  • Use these findings to help develop better therapies & improve quality of life for people with SCI.

Process

  • Recruitment and consent: Participants are recruited from the Bronx VA to complete a screening and consent process.
  • Participants will complete a surgical consent process with a Columbia University neurosurgeon before temporary electrodes are surgically placed near the cervical spinal cord at Och Spine Hospital.
  • Participants undergo sessions to map motor responses and fine-tune SCS settings
  • Brain and spinal cord activity, as well as arm and hand function, are measured with and without stimulation.
  • Participants receive SCS paired with occupational therapy (OT) in daily sessions. Clinical assessments are done midway through therapy to monitor progress.
  • After therapy, participants undergo repeat clinical and physiology tests to evaluate improvements.

Contact

If you are interested in participating in the genetics study or getting more information, please contact cpresearch@cumc.columbia.edu(link sends e-mail).

Arcim System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury

Overview

Spinal cord injury (SCI) often disrupts the body’s automatic ability to regulate blood pressure. This dysfunction often manifests as orthostatic hypotension, a severe drop in blood pressure when sitting or standing, which involves sudden and dangerously high spikes in blood pressure. For many, current treatments like medications or compression stockings aren't enough, leaving them with limited independence and a high risk of cardiovascular complications.

We have partnered with the Bronx VA and Onward Medical to study how the ARCᵀᴹ System, an implantable neurostimulation device, may help people with chronic spinal cord injury better manage blood pressure instability. As part of the study, participants will have a small lead and pulse generator implanted to deliver stimulation to the spinal cord. Throughout the study, stimulation settings will be personalized to help stabilize blood pressure, participants will receive guided at home therapy, and clinical assessments will be used to measure changes in symptoms and quality of life.

Study Goals

  • Stabilize blood pressure: Reduce dangerous spikes and drops in blood pressure.
  • Improve quality of life: Support greater daily independence.

Study Process

  • Screening and consent take place at the Bronx VA.
  • Participants then have the ARCᵀᴹ System surgically implanted at Columbia University.
  • After surgery, participants are randomly assigned to receive either active therapy or no stimulation for the first 3 months.
  • Therapy begins shortly after surgery and is used at home.
  • At 3 months, all participants receive active therapy.
  • Participants are followed for up to 24 months to monitor blood pressure and quality of life.

Contact

If you are interested in participating in the genetics study or getting more information, please contact cpresearch@cumc.columbia.edu(link sends e-mail).

Paired Brain and Peripheral Nerve Stimulation in Cerebral Palsy

Characterization of soft tissue in neuromuscular contracture

Principal Investigator: Alice H. Huang, PhD, Joshua E. Hyman, MD

This study collects human tendon tissues from pediatric patients with fixed neuromuscular contractures for RNA sequencing and histology to characterize tendon signaling, fibrosis, and tissue properties to determine the tendon specific changes that occur in neuromuscular contracture. 

Contact Information : mme2145@cumc.columbia

Non-invasive characterization of neuromuscular contracture

Principal Investigator: Joshua E. Hyman, MD

This study uses ultrasound to characterize changes of muscle, tendon, and MTJ during neuromuscular contracture (NC) formation in CP compared to typically developing (TD) children, and to track longitudinal changes to a critical age at which treatment options for respective tissues are most effective. Typically developing children include children with no neuromuscular disease. Lastly, by stratifying by prior treatments this proposal will seek to determine if current treatments for spasticity have any associations with changes in tissue-specific length or architecture.

Contact: mme2145@cumc.columbia.edu  

Postural and Reaching Control Training using Trunk-Support-Trainer (TruST)

This no-cost interventional study evaluates how an automated Trunk-Support Trainer (TruST) compares with a rigid trunk support during an intensive postural-reaching intervention for children with bilateral cerebral palsy. All children will receive the same intervention from a trained physical therapist, and participants will be randomly assigned to use either the automated TruST or the rigid trunk support.

Contact information for interested patients: cpresearch@tc.columbia.edu / 212-678-3332

Bimanual Training & Transcranial Direct Current Stimulation (tDCS)

This free study explores whether combining bimanual training with non-invasive brain stimulation can improve hand and arm function in children with unilateral cerebral palsy.

Contact information for interested patients: cpresearch@tc.columbia.edu / 212-678-3332