Can a 'Smart Bridge' in the spine help paralyzed patients walk again?
NCT ID NCT04302259
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This early study tests an implanted device called the Intelligent Spine Interface (ISI-C) in people with spinal cord injuries. The device is designed to bridge the gap in the spinal cord, picking up signals from above the injury and sending them to nerves below. The goal is to understand how nerve signals travel and to see if this approach can help patients regain lower limb function. The study involves surgical implantation, imaging, and rehabilitation, with a focus on safety and feasibility.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intelligent Spine Interface (ISI-C), an implanted epidural electrical stimulation device
- What this could lead to
- If successful, this device could help people with spinal cord injuries regain movement and function in their lower limbs.
- What could go wrong
- This is an early, small study focused on safety and feasibility. The device requires surgery, and it's uncertain if it will provide meaningful functional improvement.
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
-
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
-
3 people
The number who actually took part.
- Started
-
Sep 2021
- Finished
-
Jun 2025
- 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 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: * • Adults (men or women) between the ages of 18 and 65 years old * Complete or Incomplete SCI with AIS grade of A or B between the levels of C7/T1 and T10 (level and degree of injury based on the international standards for neurological classification of SCI (ISNCSCI)) * Focal area of SCI due to trauma * SCI date of injury \> 1 year prior to enrollment * Completed prior SCI rehabilitation program * Ability to use both upper extremities to ambulate with a wheelchair or crutches * Distance between the conus medullaris and site of injury must be \> 4 cm * The ability to participate in intensive physical therapy and research \> 4 hours per day for 2 weeks * Must provide informed consent prior to study participation Exclusion Criteria: * • Presence of co-existing lower extremity neuropathy or disorders of the cauda equina * Presence of non-traumatic spinal cord pathology * Significant cognitive impairment or decreased level of consciousness * Presence of an intrathecal baclofen or morphine pump * Presence of a cardiac defibrillator or pacemaker * Presence of a deep brain stimulator device * Patient who has any contraindication to having a MRI performed * Severe or disabling joint contractures in the lower extremities * Presence of hematologic disorder or medication related coagulopathy that would preclude surgery * Lower extremity congenital or acquired deformities * Women who are pregnant or who are unwilling to use contraception during the study period * Body mass index \> 30 * Cardiopulmonary comorbidities that preclude participation in intensive physical therapy * Known or suspected patient non-compliance during the study period and at follow up * Patient life expectancy \< 12 months * Presence of patient comorbidities or spinal anatomy that would preclude participation in the study per investigators' recommendation
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Spinal cord injury are added.
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
-
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Self-Balancing exoskeleton make daily tasks more satisfying than a wheelchair?
- Spinal implant aims to restore bladder control after paralysis
- Scientists map the daily rhythms of chronic pain
- Can AI learn to tune spinal cord stimulators?
- Which bowel care tool wins the race? trial pits suppository, enema, and irrigation device
- Robotic exoskeletons go home: can daily wear change life after spinal cord injury?