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Can a 'Smart Bridge' in the spine help paralyzed patients walk again?

NCT ID NCT04302259

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

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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

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.