Transformation of Paralysis to Stepping
About this trial
This trial is enrolling individuals with chronic thoracic (chest area) spinal cord injuries to test the effect of combining skin-surface spinal cord stimulation with the drug Buspirone on stepping function. Trial participants will be assigned to one of three study groups: Group 1: Participants with complete injuries will receive stepping training for 3-4 months using a bodyweight supported treadmill. Then, participants will get skin surface (transcutaneous) spinal cord stimulation (TSCS) along with 2-hour training sessions, 3 days/week in a gravity neutral device (legs suspended by small slings). Lastly, participants will undergo the same training with daily intake of either Buspirone or placebo, crossing over to the opposite medication halfway through the study Group 2: Participants with complete injuries will start with stepping training using an external powered robotic device to assist movement (EKSO Exoskeleton). The participants will then undergo 2-hour training sessions, 3 days/week in the EKSO device with TSCS and oral drug (Buspirone or placebo). Afterwards, participants will train 2 sessions/week in the EKSO device with TSCS and 1 session/week with a rolling walker and TSCS. Lastly, participants will train 2 sessions/week with a rolling walker, TSCS, and a drug (Buspirone or placebo). Group 3: Participants with incomplete injuries will start with stepping training in the EKSO device. Participants will then train 3 days/week for 1 hour in the EKSO device with TSCS and then 1 hour with a rolling walker and TSCS stimulation. Lastly, participants will undergo the same training with daily intake of a drug (Buspirone or placebo). Participants will be followed over a 5 year period
Included participants
Traumatic
Non-traumatic
What’s involved
Type
Details
Participants with a high to mid level thoracic SCI (T2-T7) should be prepared to participate for up to 4 months continuously at the Louisville location with a long-term follow-up one year after training.
Potential benefits
Main benefits
Standing/walking/mobility
Additional benefits
Arm/hand function
Bladder health/function
Bone health
Bowel health
General health
Sensory function
Spasticity
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- Active
- Trial start date
- 30 Sep 2019
- Organisation
- University of Louisville
- Trial recruitment status
- Active
- Trial start date
- 30 Sep 2019
- Organisation
- University of Louisville
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more