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Spinal shock: new combo may get paralyzed patients stepping overground

NCT ID NCT04105114

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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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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

  • Frazier Rehabilitation and Neuroscience Institute

    Louisville, Kentucky, 40202, United States

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