Spinal implant sparks hope for leg movement in paralyzed patients
NCT ID NCT03026816
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a method to fine-tune epidural spinal cord stimulation in 100 adults with complete spinal cord injuries between C6 and T10. The goal is to help them regain voluntary leg movement and improve functions like blood pressure control. Participants must be at least 22, stable, and more than one year post-injury.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2017
- Expected to finish
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Jan 2028
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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22 years and older
- 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: * 22 years of age or older * Able to undergo the informed consent/assent process * Stable, motor-complete paraplegia * Discrete spinal cord injury between C6 and T10 * ASIA A or B Spinal Cord Injury Classification * Medically stable in the judgement of the principal investigator * Intact segmental reflexes below the lesion of injury * Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation * Willing to attend all scheduled appointments Exclusion Criteria: * Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues) * Inability to withhold antiplatelet/anticoagulation agents perioperatively * Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP \< 50 or \>200. * Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator * Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator * Clinically significant mental illness in the judgement of the principal investigator * Botulinum toxin injections in the previous 6 months * Volitional movements present during EMG testing in bilateral lower extremities * Unhealed spinal fracture * Presence of significant contracture * Presence of pressure ulcers * Recurrent urinary tract infection refractory to antibiotics * Current Pregnancy
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hennepin County Medical Center
RECRUITINGMinneapolis, Minnesota, 55415, 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?