Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SURe)

We’re enrolling individuals with cervical spinal cord injury (SCI) to participate in a study comparing the safety, feasibility and tolerability of immediate versus delayed minimally invasive spinal stimulation when used at home or in the community.  It will also look at how this treatment works alongside a home exercise program focused on improving arm and hand function, and how both methods together affect changes in upper body function.

About the Study

Individuals enrolled in this study will be randomly assigned to one of two groups:

1. upper extremity functional task-specific training combined with minimally invasive transcutaneous spinal stimulation, or
2. waitlist control, which involves the same intervention, but with a 12-week delayed start.

Randomized means your group assignment will be decided by chance, like flipping a coin.

Depending on randomization assignment, enrollees will be asked to engage in either a 13- or 25-week enrollment period. Participants will complete initial testing once if assigned to group 1 and three times over 12 weeks if assigned to group 2.  After all initial testing is complete, participants will be asked to engage in 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference) over eight weeks followed by two evaluations after treatment.

To be eligible, you must meet the following criteria:

• be at least 18 years of age
• history of traumatic SCI (less than 12 months post injury)
• injury level of C1-C8
• categorized as AIS B-D
• have passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows
• have caregiver support to complete in-clinic trainings and at home sessions
• experience no complicating physical or cognitive conditions as determined by their physician that would preclude the safe use of electrical stimulation
• if using antispasmodics, be on a stable dose for past four weeks
• no Botox to upper extremities in the past three months
• no prior nerve or tendon transfers in the upper extremities
• no implanted electrical medical devices such as intrathecal pumps, pacemakers, and spinal stimulators

If interested, contact Bria Mellick at 303-789-8757 or bmellick@craighospital.org.

If you are interested in participating in this or future research studies at Craig Hospital, complete this survey to be added to our Research Registry.