Spinal implant aims to restore body control after paralysis
NCT ID NCT06410001
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether an implanted spinal cord stimulator can improve autonomic functions like blood pressure and heart rate in people with chronic cervical spinal cord injury. The device delivers electrical pulses to the spinal cord to help regulate involuntary body processes. The trial will enroll 36 adults with stable, motor-complete injuries between the C4 and C7 vertebrae, and will primarily assess safety while also measuring changes in blood pressure, heart rate, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Epidural spinal cord stimulation device (Abbott Eterna system)
- What this could lead to
- If successful, this could improve blood pressure control, heart rate, and overall quality of life for people with chronic cervical spinal cord injury.
- What could go wrong
- This is an early-phase trial with only 36 participants, so results may not apply to everyone. Risks include infection, bleeding, and cerebrospinal fluid leak from the implant procedure.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jul 2030
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.
Show the full entry requirements Hide 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: * Twenty two years of age or older * Able to undergo the informed consent/assent process * Stable, motor-complete SCI * Discrete SCI between C4 and C7 (upper extremity weakness) * ASIA A or B SCI Classification * Medically stable in the judgment of the PI * 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 * Normal or corrected-to-normal vision to accurately perceive visual stimuli on the N-back task screen, and sufficient hearing ability to accurately perceive auditory stimuli during the task * Willing to attend all scheduled appointments Exclusion Criteria: * Diseases and conditions that would increase the morbidity and mortality of this surgery such as cardiopulmonary. * Individuals who require respiratory support, including ongoing or intermittent use of a ventilator and/or diaphragmatic pacer * Inability to withhold antiplatelet/anticoagulation agents perioperatively * Individuals who have history of recurrent autonomic dysreflexia in the judgment of the PI * Significant dysautonomia that would prohibit rehabilitation or any history of cerebrovascular accident or myocardial infarction associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP \< 50 or \> 200 * Failure to exhibit cardiovascular autonomic dysfunction on tilt table testing * Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgment of the PI * Patients who have participated in another study within the last 12 months in which they have received fluoroscopic or other related radiation exposure * Current and anticipated need for opioid pain medications or pain that would prevent full participation in the program in the judgment of the PI * Clinically significant mental illness in the judgment of the PI * Treatment with botulinum toxin, intrathecal baclofen pump, and antispasmodics will not be permitted unless discussed with and approved by the study PI * Patients with a history of significant depression or drug abuse * Volitional movements present during EMG testing in bilateral lower extremities * Unhealed spinal fracture * Presence of significant contracture with loss of greater than two-thirds range of motion * Presence of pressure ulcers * 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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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States
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