Transformation of Paralysis to Stepping

Technology
Standing/walking/mobility
Online since 4 November 2021, updated 844 days ago

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

Gender
All
Age
18 - 65 years
Injury level
T2 - T7
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    12 months - 65 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    T2-T7
    Additionally, participants must
    NOT have implanted device, e.g. pacemaker or baclofen pump
    NOT be dependent on ventilator
    NOT be taking anti-spasticity medications

    What’s involved

    Type

    Technology

    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

    Bone health

    Bowel health

    General health

    Mental 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
    • Recruiting
    • Trial start date
    • 30 Sep 2019
    • Organisation
    • University of Louisville
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 30 Sep 2019
    • Organisation
    • University of Louisville

    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