Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity

Launched by SHEPHERD CENTER, ATLANTA GA · Jun 22, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people with spinal cord injuries improve their ability to walk, maintain balance, and strengthen their muscles. The researchers want to see if a combination of motor skill training—exercises that help improve movement—and a technique called transcutaneous spinal stimulation (which gently stimulates the spinal cord from the outside) can lead to better results than just training alone. The goal is to find an approach that can be easily done at home, making it more accessible for those who need it.

To participate in this trial, you must be between 18 and 70 years old and have a spinal cord injury that occurred at least three months ago. You should be able to stand for at least five minutes and move each leg independently for at least three steps. Participants will receive training and stimulation in a supportive environment, and they will also need to follow some guidelines regarding medications and health conditions. This study could be an important step towards improving daily function and mobility for individuals living with spinal cord injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be 18-70 years of age
• • Have a spinal cord injury (neurological level C3-T12) that occurred ≥3 months (sub-acute to chronic) prior to enrollment
• • Have ISNCSCI severity classification C or D
• • Able to stand for at least 5 minutes (with or without the aid of an assistive device)
• • Able to move each leg independently for at least 3 steps (with or without the aid of an assistive device)
• • Able to rise from sit to stand with moderate assistance from one person
• • Use of prescription medication(s) for control of spasticity if the dosage has not changed in the last 2 weeks and you notify the study staff if your medication(s) change during study participation
• • Ability and willingness to consent and authorize use of personal health information
• • Ability to follow multiple instructions and communicate pain or discomfort
• Exclusion Criteria:
• • Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord
• • Injuries below the neurological spinal level of T12
• • Pregnant, or if you have reason to believe you are or may become pregnant due to unknown risks to the fetus associated with TSS
• • History of cardiovascular irregularities
• • Presence of orthopedic conditions that would adversely affect participation in exercise
• • Implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g., baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator, diaphragmatic pacemaker)
• • Any cuts or sensitivity of the skin near the level of stimulation
• • Active cancer or history of cancer
• • Inability and unwillingness to consent and authorize use of personal health information