Spinal Cord InjuriesNCT03669302
Activity-Dependent Transspinal Stimulation in SCI
A study testing Robotic gait training, Robotic gait training and low-frequency transspinal stimulation and Robotic gait training and high-frequency transspinal stimulation in people with Spinal Cord Injuries and Paraplegia, Spinal, run by City University of New York at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Paraplegia, Spinal, Tetraplegia/Tetraparesis
- What is being tested?
- Robotic gait training, Robotic gait training and low-frequency transspinal stimulation and Robotic gait training and high-frequency transspinal stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2018to 2 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Physical Therapy, Motor Control and NeuroRecovery Laboratory
Staten Island, New York, 10314
Veterans Affairs Medical Center
The Bronx, New York, 10468
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Robotic gait training, Robotic gait training and low-frequency transspinal stimulation, Robotic gait training and high-frequency transspinal stimulation
- Keywords
- locomotor training, transcutaneous spinal cord stimulation, Lokomat, brain stimulation, peripheral nerve stimulation, H-reflex, spinal neural circuits, neuroplasticity, recovery
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic gait trainingOther
Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
Robotic gait training and low-frequency transspinal stimulationDevice
Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a single pulse at 0.3 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
Robotic gait training and high-frequency transspinal stimulationDevice
Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
| Study group | Role | What they receive |
|---|---|---|
| Robotic gait training | Sham comparator | Robotic gait training only Receives: Other: Robotic gait training |
| Robotic gait training & low-frequeny transspinal stimulation. | Experimental | Robotic gait training will be administered along with non-invasive transspinal stimulation over the thoracolumbar region during assisted stepping at low frequency (0.3 Hz). Receives: Device: Robotic gait training and low-frequency transspinal stimulation |
| Robotic gait training & high-frequeny transspinal stimulation. | Experimental | Robotic gait training will be administered along with non-invasive transspinal stimulation over the thoracolumbar region during assisted stepping at high frequency (30 Hz). Receives: Device: Robotic gait training and high-frequency transspinal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasticity of cortical and corticospinal neuronal circuits
Neurophysiological tests probing cortical and corticospinal excitability will be measured before and after the intervention. Single-pulse transcranial magnetic stimulation (TMS) will be used to assemble the recruitment curve of motor evoked potentials, and paired-pulse TMS will be used to probe changes in cortical inhibitory and facilitatory neuronal circuits.
Measured: 3 years
Plasticity of spinal neuronal circuits
Neurophysiological tests probing spinal reflex excitability will be measured before and after each intervention by posterior tibial and sural nerves stimulation during Lokomat-assisted stepping depicting the amplitude modulation of the soleus H-reflex and tibialis anterior flexor reflex.
Measured: 3 years
Secondary outcomes (3)
Senorimotor leg motor function
Manual muscle test and leg sensation based on American Spinal Injury Association guidelines.
Measured: 3 years
Spasticity
Tardieu scale
Measured: 3 years
Walking function
Two-minute walk test and 10 meter timed test.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Aug 2018
- Primary completion1 Oct 2021
- Study completion2 Oct 2021
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals with Spinal Cord Imjury will be randomly assigned to receive robotic gait training with the Lokomat, and/or Lokomat gait training combined with non-invasive thoracolumbar transspinal stimulation at 0.3 or at 30 Hz.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Bronx Veterans Medical Research Foundation, Inc
- Responsible party
- Principal investigator, Maria Knikou, PT, PhD, City University of New York
- Investigators
- Maria Knikou, PT, PhD, Principal investigator, Research Foundation of the City University of New YorkNoam Y Harel, MD, PhD, Principal investigator, VA Office of Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669302
- Sponsor's protocol ID
- C33276GG
- Status last verified
- Aug 2022
- First submitted
- 11 Sep 2018
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Marino RJ, Barros T, Biering-Sorensen F, Burns SP, Donovan WH, Graves DE, Haak M, Hudson LM, Priebe MM; ASIA Neurological Standards Committee 2002. International standards for neurological classification of spinal cord injury. J Spinal Cord Med. 2003 Spring;26 Suppl 1:S50-6. doi: 10.1080/10790268.2003.11754575. No abstract available.
PubMed 16296564Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
PubMed 19833552Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8.
PubMed 9474057Adams MM, Ginis KA, Hicks AL. The spinal cord injury spasticity evaluation tool: development and evaluation. Arch Phys Med Rehabil. 2007 Sep;88(9):1185-92. doi: 10.1016/j.apmr.2007.06.012.
PubMed 17826466Barbeau H, Wainberg M, Finch L. Description and application of a system for locomotor rehabilitation. Med Biol Eng Comput. 1987 May;25(3):341-4. doi: 10.1007/BF02447435. No abstract available.
PubMed 3449731Carmel JB, Berrol LJ, Brus-Ramer M, Martin JH. Chronic electrical stimulation of the intact corticospinal system after unilateral injury restores skilled locomotor control and promotes spinal axon outgrowth. J Neurosci. 2010 Aug 11;30(32):10918-26. doi: 10.1523/JNEUROSCI.1435-10.2010.
PubMed 20702720Chang CW, Lien IN. Estimate of motor conduction in human spinal cord: slowed conduction in spinal cord injury. Muscle Nerve. 1991 Oct;14(10):990-6. doi: 10.1002/mus.880141010.
PubMed 1944412Chen R, Tam A, Butefisch C, Corwell B, Ziemann U, Rothwell JC, Cohen LG. Intracortical inhibition and facilitation in different representations of the human motor cortex. J Neurophysiol. 1998 Dec;80(6):2870-81. doi: 10.1152/jn.1998.80.6.2870.
PubMed 9862891Colombo G, Wirz M, Dietz V. Driven gait orthosis for improvement of locomotor training in paraplegic patients. Spinal Cord. 2001 May;39(5):252-5. doi: 10.1038/sj.sc.3101154.
PubMed 11438840Conway BA, Knikou M. The action of plantar pressure on flexion reflex pathways in the isolated human spinal cord. Clin Neurophysiol. 2008 Apr;119(4):892-6. doi: 10.1016/j.clinph.2007.12.015. Epub 2008 Mar 4.
PubMed 18289932Dimitrijevic MM, Dimitrijevic MR, Illis LS, Nakajima K, Sharkey PC, Sherwood AM. Spinal cord stimulation for the control of spasticity in patients with chronic spinal cord injury: I. Clinical observations. Cent Nerv Syst Trauma. 1986 Spring;3(2):129-44. doi: 10.1089/cns.1986.3.129.
PubMed 3490312Dimitrijevic MR, Illis LS, Nakajima K, Sharkey PC, Sherwood AM. Spinal cord stimulation for the control of spasticity in patients with chronic spinal cord injury: II. Neurophysiologic observations. Cent Nerv Syst Trauma. 1986 Spring;3(2):145-52. doi: 10.1089/cns.1986.3.145.
PubMed 3490313Dobkin B, Apple D, Barbeau H, Basso M, Behrman A, Deforge D, Ditunno J, Dudley G, Elashoff R, Fugate L, Harkema S, Saulino M, Scott M; Spinal Cord Injury Locomotor Trial Group. Weight-supported treadmill vs over-ground training for walking after acute incomplete SCI. Neurology. 2006 Feb 28;66(4):484-93. doi: 10.1212/01.wnl.0000202600.72018.39.
PubMed 16505299Dy CJ, Gerasimenko YP, Edgerton VR, Dyhre-Poulsen P, Courtine G, Harkema SJ. Phase-dependent modulation of percutaneously elicited multisegmental muscle responses after spinal cord injury. J Neurophysiol. 2010 May;103(5):2808-20. doi: 10.1152/jn.00316.2009.
PubMed 20357075Einhorn J, Li A, Hazan R, Knikou M. Cervicothoracic multisegmental transpinal evoked potentials in humans. PLoS One. 2013 Oct 7;8(10):e76940. doi: 10.1371/journal.pone.0076940. eCollection 2013.
PubMed 24282479
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity-Dependent Transspinal Stimulation for Recovery of Walking Ability After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03669302
- Acronym / sponsor ID
- C33276GG
- Keywords
- locomotor training, transcutaneous spinal cord stimulation, Lokomat, brain stimulation, peripheral nerve stimulation, H-reflex, spinal neural circuits, neuroplasticity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID
- Enrolment
- 10 participants (actual)
- Lead sponsor
- City University of New YorkUniversity, hospital or other
- Collaborators
- Bronx Veterans Medical Research Foundation, Inc
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 2 Oct 2021 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Individuals with Spinal Cord Imjury will be randomly assigned to receive robotic gait training with the Lokomat, and/or Lokomat gait training combined with non-invasive thoracolumbar transspinal stimulation at 0.3 or at 30 Hz.
| Arm | Type | Receives |
|---|---|---|
| Robotic gait training | Sham comparator | Other: Robotic gait trainingRobotic gait training only |
| Robotic gait training & low-frequeny transspinal stimulation. | Experimental | Device: Robotic gait training and low-frequency transspinal stimulationRobotic gait training will be administered along with non-invasive transspinal stimulation over the thoracolumbar region during assisted stepping at low frequency (0.3 Hz). |
| Robotic gait training & high-frequeny transspinal stimulation. | Experimental | Device: Robotic gait training and high-frequency transspinal stimulationRobotic gait training will be administered along with non-invasive transspinal stimulation over the thoracolumbar region during assisted stepping at high frequency (30 Hz). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Supraspinal lesions
- Neuropathies of the peripheral nervous system
- Degenerative neurological disorders of the spine or spinal cord
- Motor complete SCI
- Presence of pressure sores
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic gait trainingFifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function. | Other | Robotic gait training |
| Robotic gait training and low-frequency transspinal stimulationFifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a single pulse at 0.3 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function. | Device | Robotic gait training & low-frequeny transspinal stimulation. |
| Robotic gait training and high-frequency transspinal stimulationFifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function. | Device | Robotic gait training & high-frequeny transspinal stimulation. |
Primary outcome
Plasticity of cortical and corticospinal neuronal circuits
Time frame: 3 years
Neurophysiological tests probing cortical and corticospinal excitability will be measured before and after the intervention. Single-pulse transcranial magnetic stimulation (TMS) will be used to assemble the recruitment curve of motor evoked potentials, and paired-pulse TMS will be used to probe changes in cortical inhibitory and facilitatory neuronal circuits.
Plasticity of spinal neuronal circuits
Time frame: 3 years
Neurophysiological tests probing spinal reflex excitability will be measured before and after each intervention by posterior tibial and sural nerves stimulation during Lokomat-assisted stepping depicting the amplitude modulation of the soleus H-reflex and tibialis anterior flexor reflex.
3 secondary outcomes
Senorimotor leg motor function
Time frame: 3 years
Spasticity
Time frame: 3 years
Walking function
Time frame: 3 years
Results and safety
The study was stopped early (reason given: COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Background: PubMed 16296564Marino RJ, Barros T, Biering-Sorensen F, Burns SP, Donovan WH, Graves DE, Haak M, Hudson LM, Priebe MM; ASIA Neurological Standards Committee 2002. International standards for neurological classification of spinal cord injury. J Spinal Cord Med. 2003 Spring;26 Suppl 1:S50-6. doi: 10.1080/10790268.2003.11754575. No abstract available.
- Background: PubMed 19833552Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
- Background: PubMed 9474057Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8.
- Background: PubMed 17826466Adams MM, Ginis KA, Hicks AL. The spinal cord injury spasticity evaluation tool: development and evaluation. Arch Phys Med Rehabil. 2007 Sep;88(9):1185-92. doi: 10.1016/j.apmr.2007.06.012.
- Background: PubMed 3449731Barbeau H, Wainberg M, Finch L. Description and application of a system for locomotor rehabilitation. Med Biol Eng Comput. 1987 May;25(3):341-4. doi: 10.1007/BF02447435. No abstract available.
- Background: PubMed 20702720Carmel JB, Berrol LJ, Brus-Ramer M, Martin JH. Chronic electrical stimulation of the intact corticospinal system after unilateral injury restores skilled locomotor control and promotes spinal axon outgrowth. J Neurosci. 2010 Aug 11;30(32):10918-26. doi: 10.1523/JNEUROSCI.1435-10.2010.
- Background: PubMed 1944412Chang CW, Lien IN. Estimate of motor conduction in human spinal cord: slowed conduction in spinal cord injury. Muscle Nerve. 1991 Oct;14(10):990-6. doi: 10.1002/mus.880141010.
- Background: PubMed 9862891Chen R, Tam A, Butefisch C, Corwell B, Ziemann U, Rothwell JC, Cohen LG. Intracortical inhibition and facilitation in different representations of the human motor cortex. J Neurophysiol. 1998 Dec;80(6):2870-81. doi: 10.1152/jn.1998.80.6.2870.
- Background: PubMed 11438840Colombo G, Wirz M, Dietz V. Driven gait orthosis for improvement of locomotor training in paraplegic patients. Spinal Cord. 2001 May;39(5):252-5. doi: 10.1038/sj.sc.3101154.
- Background: PubMed 18289932Conway BA, Knikou M. The action of plantar pressure on flexion reflex pathways in the isolated human spinal cord. Clin Neurophysiol. 2008 Apr;119(4):892-6. doi: 10.1016/j.clinph.2007.12.015. Epub 2008 Mar 4.
- Background: PubMed 3490312Dimitrijevic MM, Dimitrijevic MR, Illis LS, Nakajima K, Sharkey PC, Sherwood AM. Spinal cord stimulation for the control of spasticity in patients with chronic spinal cord injury: I. Clinical observations. Cent Nerv Syst Trauma. 1986 Spring;3(2):129-44. doi: 10.1089/cns.1986.3.129.
- Background: PubMed 3490313Dimitrijevic MR, Illis LS, Nakajima K, Sharkey PC, Sherwood AM. Spinal cord stimulation for the control of spasticity in patients with chronic spinal cord injury: II. Neurophysiologic observations. Cent Nerv Syst Trauma. 1986 Spring;3(2):145-52. doi: 10.1089/cns.1986.3.145.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Knikou, PT, PhD principal investigator
Research Foundation of the City University of New York
Noam Y Harel, MD, PhD principal investigator
VA Office of Research and Development
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic gait training, Robotic gait training and low-frequency transspinal stimulation and Robotic gait training and high-frequency transspinal stimulation in people with Spinal Cord Injuries and Paraplegia, Spinal, run by City University of New York at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasticity of cortical and corticospinal neuronal circuits (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03669302, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.