University of Louisville
Louisville, Kentucky, 40202, United States
NCT Number: NCT02339233
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Louisville, Kentucky, 40202, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion 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
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.
Other names: Stand-scES, Step-scES, Locomotor Training (LT)
Time frame: Baseline, 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 session (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 sessions (1 year)
We will measure the ability of the individuals to perform consecutive hip flexion repetitions with stimulation during a 1 minute period
University of Louisville
Other
Spinal Epidural Electrode Array to Facilitate Standing and Stepping After Spinal Cord Injury
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