Activity-Dependent Transspinal Stimulation in SCI
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 9/15/2018 |
| Start Date: | August 1, 2018 |
| End Date: | May 30, 2021 |
| Contact: | Maria Knikou, PT, PhD |
| Email: | Maria.Knikou@csi.cuny.edu |
| Phone: | 17189823316 |
Activity-Dependent Transspinal Stimulation for Recovery of Walking Ability After Spinal Cord Injury
Robotic gait training is often used with the aim to improve walking ability in individuals
with Spinal Cord Injury. However, robotic gait training alone may not be sufficient. This
study will compare the effects of robotic gait training alone to robotic gait training
combined with either low-frequency or high-frequency non-invasive transspinal electrical
stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests
of nerve function will be performed before and after 20 sessions of gait training with or
without stimulation.
with Spinal Cord Injury. However, robotic gait training alone may not be sufficient. This
study will compare the effects of robotic gait training alone to robotic gait training
combined with either low-frequency or high-frequency non-invasive transspinal electrical
stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests
of nerve function will be performed before and after 20 sessions of gait training with or
without stimulation.
People with spinal cord injury (SCI) have motor dysfunction that results in substantial
social, personal, and economic costs. Robotic gait training is often used with the aim to
improve walking ability in these individuals. Investigators recently reported that robotic
gait training reorganizes spinal neuronal circuits, improves motor activity, and contributes
substantially to recovery of walking ability in people with motor incomplete SCI. However,
pathological muscle tone and abnormal muscle activation patterns during assisted stepping
were still evident after multiple sessions of robotic gait training. Locomotor training alone
may thus be insufficient to strengthen weak neuronal synapses connecting the brain with the
spinal cord or to fully optimize spinal neural circuits. On the other hand, spinal cord
stimulation increases sprouting and plasticity of axons and dendrites in spinalized animals.
Furthermore, transcutaneous spinal cord stimulation (termed here transspinal stimulation) in
people with SCI can evoke rhythmic leg muscle activity when gravity is eliminated. A
fundamental knowledge gap still exists on induction of functional neuroplasticity and
recovery of leg motor function after repetitive thoracolumbar transspinal stimulation during
body weight supported (BWS) assisted stepping in people with SCI. The central working
hypothesis in this study is that transspinal stimulation delivered during BWS-assisted
stepping provides a tonic excitatory input increasing the overall responsiveness of the
spinal cord and improving motor output. The investigators will address 3 specific aims:
Establish induction of neuroplasticity and improvements in leg sensorimotor function in
people with motor incomplete SCI when transspinal stimulation is delivered during
BWS-assisted stepping at low frequencies (0.3 Hz; Specific Aim 1) and at high frequencies (30
Hz; Specific Aim 2), and when BWS-assisted step training is administered without transspinal
stimulation (Specific Aim 3). In all groups, outcomes after 20 sessions will be measured via
state-of-the-art neurophysiological methods. Corticospinal circuit excitability will be
measured via transcranial magnetic stimulation motor evoked potentials in seated subjects
(Aims 1A, 2A, 3A). Soleus H-reflex and tibialis anterior flexor reflex excitability patterns
will be measured during assisted stepping (Aims 1B, 2B, 3B). Sensorimotor function will be
evaluated via standardized clinical tests of gait and strength (Aims 1C, 2C, 3C).
Additionally, poly-electromyographic analysis of coordinated muscle activation will be
measured in detail. It is hypothesized that transspinal stimulation at 30 Hz during assisted
stepping improves leg motor function and decreases ankle spasticity more compared to 0.3 Hz.
It is further hypothesized that transspinal stimulation at 30 Hz normalizes the abnormal
phase-dependent soleus H-reflex and flexor reflex modulation commonly observed during
stepping in people with motor incomplete SCI. To test the project hypotheses, 45 people with
motor incomplete SCI will be randomly assigned to receive 20 sessions of transspinal
stimulation at 0.3 or 30 Hz during BWS-assisted stepping or 20 sessions of BWS-assisted
stepping without transspinal stimulation (15 subjects per group). Results from this research
project will advance considerably the field of spinal cord research and change the standard
of care because there is great potential for development of novel and effective
rehabilitation strategies to improve leg motor function after motor incomplete SCI in humans.
social, personal, and economic costs. Robotic gait training is often used with the aim to
improve walking ability in these individuals. Investigators recently reported that robotic
gait training reorganizes spinal neuronal circuits, improves motor activity, and contributes
substantially to recovery of walking ability in people with motor incomplete SCI. However,
pathological muscle tone and abnormal muscle activation patterns during assisted stepping
were still evident after multiple sessions of robotic gait training. Locomotor training alone
may thus be insufficient to strengthen weak neuronal synapses connecting the brain with the
spinal cord or to fully optimize spinal neural circuits. On the other hand, spinal cord
stimulation increases sprouting and plasticity of axons and dendrites in spinalized animals.
Furthermore, transcutaneous spinal cord stimulation (termed here transspinal stimulation) in
people with SCI can evoke rhythmic leg muscle activity when gravity is eliminated. A
fundamental knowledge gap still exists on induction of functional neuroplasticity and
recovery of leg motor function after repetitive thoracolumbar transspinal stimulation during
body weight supported (BWS) assisted stepping in people with SCI. The central working
hypothesis in this study is that transspinal stimulation delivered during BWS-assisted
stepping provides a tonic excitatory input increasing the overall responsiveness of the
spinal cord and improving motor output. The investigators will address 3 specific aims:
Establish induction of neuroplasticity and improvements in leg sensorimotor function in
people with motor incomplete SCI when transspinal stimulation is delivered during
BWS-assisted stepping at low frequencies (0.3 Hz; Specific Aim 1) and at high frequencies (30
Hz; Specific Aim 2), and when BWS-assisted step training is administered without transspinal
stimulation (Specific Aim 3). In all groups, outcomes after 20 sessions will be measured via
state-of-the-art neurophysiological methods. Corticospinal circuit excitability will be
measured via transcranial magnetic stimulation motor evoked potentials in seated subjects
(Aims 1A, 2A, 3A). Soleus H-reflex and tibialis anterior flexor reflex excitability patterns
will be measured during assisted stepping (Aims 1B, 2B, 3B). Sensorimotor function will be
evaluated via standardized clinical tests of gait and strength (Aims 1C, 2C, 3C).
Additionally, poly-electromyographic analysis of coordinated muscle activation will be
measured in detail. It is hypothesized that transspinal stimulation at 30 Hz during assisted
stepping improves leg motor function and decreases ankle spasticity more compared to 0.3 Hz.
It is further hypothesized that transspinal stimulation at 30 Hz normalizes the abnormal
phase-dependent soleus H-reflex and flexor reflex modulation commonly observed during
stepping in people with motor incomplete SCI. To test the project hypotheses, 45 people with
motor incomplete SCI will be randomly assigned to receive 20 sessions of transspinal
stimulation at 0.3 or 30 Hz during BWS-assisted stepping or 20 sessions of BWS-assisted
stepping without transspinal stimulation (15 subjects per group). Results from this research
project will advance considerably the field of spinal cord research and change the standard
of care because there is great potential for development of novel and effective
rehabilitation strategies to improve leg motor function after motor incomplete SCI in humans.
Inclusion criteria:
- Clinical diagnosis of motor incomplete spinal cord injury (SCI).
- SCI is above thoracic 12 vertebra.
- Absent permanent ankle joint contractures.
- SCI occurred 6 months before enrollment to the study.
Exclusion criteria:
- Supraspinal lesions
- Neuropathies of the peripheral nervous system
- Degenerative neurological disorders of the spine or spinal cord
- Motor complete SCI
- Presence of pressure sores
- Urinary tract infection
- Neoplastic or vascular disorders of the spine or spinal cord
- Pregnant women or women who suspect they may be or may become pregnant.
- People with cochlear implants, pacemaker and implanted stimulators
- People with history of seizures
- People with implanted Baclofen pumb
We found this trial at
2
sites
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Staten Island, New York 10314
Phone: 718-982-3316
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