An interventional study of Standing and Stepping with spinal cord Epidural Stimulation in Spinal Cord Injury, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by University of Louisville · Not applicable, Interventional, and Basic science
The overall aim is to assess whether task specific locomotor training and spinal cord electrical stimulation (SCES) can induce neural reorganization of the functionally isolated human spinal cord to improve standing and stepping in individuals with functionally complete SCI. The investigators propose that locomotor training will result in generation of more effective standing and stepping efferent patterns by restoring phase dependent modulation of reflexes and reciprocal inhibition, reducing clonus and mediating interlimb coordination. The investigators propose that the SCES will optimize the physiological state of the spinal cord interneuronal circuitry compromised by compensating for loss of supraspinal input for the retraining of these tasks.
Participants will be screened for eligibility and then participate in pre-training motor, bladder and cardiovascular experiments, followed by 80 sessions of locomotor training. Participants will repeat experiments after the 80 training sessions to quantify that no motor pattern changes are achievable with locomotor training alone and will be evaluated for appropriate candidacy for surgery and epidural stimulation. Participants will be surgically implanted with an epidural stimulator and experiments will be conducted with and without stimulation. Investigators will identify appropriate stimulation parameters for inducing stepping and standing in combination with manual assistance using body weight support on a treadmill and/or overground. Participants will undergo 80-200 training sessions of locomotor training with epidural stimulation. Experiments will be repeated mid and post-training interventions.
1,991 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.
This study's enrollment of 8 is below the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Louisville is the lead sponsor of 290 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
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All research participants, irrespective of age or sex, will meet the following criteria:
In addition, all subjects must satisfy each of the three conditions of the functional neurophysiological assessment described below.
Functional Neurophysiological Assessment (FNPA). We will use FNPA to screen potential research participants based on specific neurophysiological inclusion criteria. Participants must have no volitional control of movement below the level of the lesion, but must retain some brain influence on spinal reflexes. Our target population, which will be identified by FNPA, cannot be identified reliable using traditional assessments: hence individual subjects may be classified widely as Class A, B, or C on the ASIA SCI scale. We will include only subjects who fulfill the following three requirements:
Exclusion Criteria:
Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord
Device: Standing and Stepping with spinal cord Epidural Stimulation
Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
Also known as: Stand-scES, Step-scES, Locomotor Training (LT)
Change From Baseline of Lower Extremity Independence Time During 10 Min Standing Bout After 160 Sessions (1 Year)
We will measure the amount of time individuals are able to stand without manual assistance (independently) throughout a 10 min bout
Time frame: Baseline, 160 sessions (1 year)
Change From Baseline of Stepping Independence Time During 6 Min Stepping Bout After 160 Sessions (1 Year)
We will measure the number of steps individuals are able to take without manual assistance (independently) throughout a 6 min stepping bout
Time frame: Baseline, 160 session (1 year)
Change From Baseline of Number of Consecutive Hip Flexion Repetitions Performed Within One Minute After 160 Sessions (1 Year)
We will measure the ability of the individuals to perform consecutive hip flexion repetitions with stimulation during a 1 minute period
Time frame: Baseline, 160 sessions (1 year)
| Milestone | Epidural Stimulator |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
We will measure the amount of time individuals are able to stand without manual assistance (independently) throughout a 10 min bout
| minutes | Epidural Stimulator |
|---|---|
| Change From Baseline of Lower Extremity Independence Time During 10 Min Standing Bout After 160 Sessions (1 Year) | 40.6 ± 30.2 |
We will measure the number of steps individuals are able to take without manual assistance (independently) throughout a 6 min stepping bout
| steps | Epidural Stimulator |
|---|---|
| Change From Baseline of Stepping Independence Time During 6 Min Stepping Bout After 160 Sessions (1 Year) | 197.13 ± 421.89 |
We will measure the ability of the individuals to perform consecutive hip flexion repetitions with stimulation during a 1 minute period
| Repetitions | Epidural Stimulator |
|---|---|
| Change From Baseline of Number of Consecutive Hip Flexion Repetitions Performed Within One Minute After 160 Sessions (1 Year) | 14.25 ± 9.8 |
Collected over From implant through the end of the second intervention, an average of one year.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epidural Stimulator | 0/8 (0%) | 2/8 (25%) | 5/8 (62.5%) |
| Event | Epidural Stimulator |
|---|---|
| Device MalfunctionSurgical and medical procedures | 1/8 |
| Hip FractureMusculoskeletal and connective tissue disorders | 1/8 |
| Event | Epidural Stimulator |
|---|---|
| Muscle StrainMusculoskeletal and connective tissue disorders | 1/8 |
| Flipped StimulatorSurgical and medical procedures | 1/8 |
| Electrode MalfunctionSurgical and medical procedures | 1/8 |
| Incision Site DrainageSkin and subcutaneous tissue disorders | 1/8 |
| Right Ankle EdemaMusculoskeletal and connective tissue disorders | 1/8 |
| Age, Categorical(Participants) | Epidural Stimulator |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Epidural Stimulator |
|---|---|
| Female | 1 |
| Male | 7 |
| Race and Ethnicity Not Collected(Participants) | Epidural Stimulator |
|---|
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