Spinal Cord Injury Research

Principal investigator

Edelle Field-Fote, PT, Ph.D., FAPTA, FASIA

About this study

Spasticity involves involuntary muscle activity in persons with spinal cord injury (SCI) that can include increased response to muscle stretch and physical touch, as well as muscle stiffness. Due to the combination of symptoms, several drug therapies are currently prescribed to reduce spasticity but they may have negative side effects including fatigue and muscle weakness. Transcutaneous spinal stimulation (TSS) is a form of electrical stimulation delivered over the skin of the spine that seems to have effects that are similar to drug therapy. Prior studies of TSS in persons with SCI suggest that TSS can reduce spasticity without negative side effects. The intensity of stimulation, or dose, that promotes the best response is not known. In addition, sensitive measurements are necessary to assess the changes that can be seen in multiple presentations of spasticity. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects of TSS as a non-drug intervention for spasticity management.

Participation eligibility

• A SCI with any severity classification (AIS A, B, C, or D) that occurred at least three months ago
• At least mild “spasticity” affecting lower extremity muscles
• Use of prescription medications is acceptable, as long as the dosage has not changed in the last two weeks and notification of medication changes is made during study participation
• Ability to follow multiple commands
• Ability to communicate pain or discomfort
• Ability and willingness to authorize the use of protected health information
• Ability and willingness to reside in Atlanta for the duration of the study

More information

More information about this clinical trial is available at SCITrials.org. If interested in participating, please contact one of our research staff below.

Evan Sandler, PT, D.P.T.
[email protected]
404-603-4175

Kelly Thatcher, PT, D.P.T.
[email protected]
404-350-7681

Principal investigator

Edelle Field-Fote, PT, Ph.D., FAPTA, FASIA

About this study

For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive spinal stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training with spinal stimulation may further enhance the restoration of function in persons with SCI. Therefore, the purpose of this study is to determine if moderate-intensity, motor skill training can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive spinal stimulation will result in greater improvements in function compared to training alone.

Participation eligibility

• A spinal cord injury (neurological level T12 or above)
• Injury occurred at least three months ago (sub-acute to chronic)
• SCI severity (AIS) classification C or D
• Ability to stand for at least five minutes (with or without an assistive device)
• Ability to move each leg independently for at least three steps
• Ability to rise from sit to stand with no more than moderate assistance from one person
• Ability and willingness to consent and authorize use of personal health information
• Ability and willingness to reside in Atlanta for the duration of the study

More information

More information about this clinical trial is available at SCITrials.org. If interested in participating, please contact one of our research staff below.

Jacob Creech, PT, D.P.T.
[email protected]
678-877-9572

Nicholas Evans, MHS, CEP
[email protected]

About this study

AXER-204 was found to help promote nerve growth and possible neurological recovery in animal laboratory studies using rats and monkeys. While a single dose is not expected to promote neurological recovery in humans, this study will confirm its safety and tolerability. A follow up study will test the potential effects of repeated doses.

This is the first clinical study to date being conducted in humans with AXER-204.

Part 1

Part 1 of the trial is a multicenter, open-label, single ascending dose study in participants with chronic cervical spinal cord injury. The purpose of Part 1 is to determine if a single dose of an investigational drug, AXER-204, can be safely injected into the spinal canal and tolerated by people with chronic spinal cord injury (SCI). Four cohorts of 6 participants each are planned, with participants within each cohort expected to receive the same dose of AXER-204.

Part 1 concluded in Summer of 2020.

Part 2

Part 2 is a multicenter, randomized, double-blind, placebo-controlled, repeat dose study in chronic cervical spinal cord injury participants. The purpose of Part 2 is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of repeated doses AXER-204 compared to placebo. Up to 42 participants will be randomized (ratio 1:1) to receive repeated doses of AXER-204 or placebo (a phosphate buffered saline formulation). The dose level and dose frequency will be dependent upon outcomes from Part 1.

Part 2 participants are currently in long term follow up; recruitment is closed.

Participation eligibility

• 18 – 65 years old
• Traumatic SCI that occurred greater than 1 year ago
• Cervical SCI with weakness in the arms and/or hands
• In excellent overall health

If any of the following apply to you, you are not eligible to participate:

• History of a stroke, brain injury, or any other chronic medical condition
  Implanted baclofen or pain pump
• Require any assistance to breathe (i.e. mechanical ventilation)
• Recent medication changes
• Penetrating Injury (i.e. Gunshot/stabbing)