Spinal shock: new combo may get paralyzed patients stepping overground
NCT ID NCT04105114
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether combining noninvasive spinal cord stimulation with the drug buspirone can help people with severe spinal cord injury take steps overground. Fifteen participants who have been paralyzed for at least a year will undergo various training and measurement sessions over five years. The goal is to restore some walking ability, not to cure the injury.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria by study group: 1. Participants with Motor Complete SCI: * 18-65 years old, * Stable medical condition, * At least 1-year post-injury, * Non-progressive SCI, * Motor complete paraplegia: Unable to voluntarily move any joint of the lower limbs, * Inability to walk independently due to SCI, * Presence of active spinally evoked responses over the lumbo-sacral spinal cord using spinal Cord Transcutaneous Stimulation (scTS). 2. Participants with Motor Incomplete SCI: * 18-65 years old, * Stable medical condition, * At least 1-year post-injury, * Non-progressive SCI, * Motor incomplete paraplegia: Able to voluntarily move at least 1 joint of the lower limbs bilaterally, * Inability to walk independently in the community due to SCI, * Presence of active spinally evoked responses over the lumbo-sacral spinal cord using scTS. Exclusion Criteria: * Untreated pressure sores, * Unhealed bone fractures, * Untreated active urinary tract infections, * Peripheral lower limb neuropathies unrelated to SCI, * Seizure disorders, * Cardiopulmonary disease unrelated to SCI, * Untreated anemia, * Ventilator dependency, * Female participants: Pregnant or planning to become pregnant during the time course of study, or nursing, * Healing wounds/surgical sites along the spine, levels T9-L5, * Anti-spasticity implantable pumps, * Untreated clinically significant depression, psychiatric disorders, or ongoing drug abuse, * Colostomy bag, urostomy, * Individuals with abnormal blood panel results related to hepatic function, Individuals with abnormal estimated glomerular filtration rate (eGFR) and increase Creatinine Clearance (CrCl) levels above the normal range, * Individuals unwilling or unable to wean from drug(s) that interact(s) with buspirone, such as: Monoamine oxidase inhibitors (MAOIs) - Selegiline (Emsam), Isocarboxazid (Marplan), Phenelzein (Nardil), and Tranylcypromine (Parnate).
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, 40202, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Serotonin precursor probed for spinal cord injury effects
- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?
- Can painless spinal zaps teach injured kids to walk again?