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Spinal implant aims to restore arm movement after paralysis

NCT ID NCT06225245

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a device that sends mild electrical pulses to the spinal cord can help people with a cervical (neck) spinal cord injury regain arm and hand function. The device, called the CoverEdgeX 32 Surgical Lead, is already approved for pain but is investigational for this use. Twelve adults aged 22-65 will receive the implant and undergo upper limb training while researchers measure muscle strength and movement.

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 Stimulation (ESS) using the CoverEdgeX 32 Surgical Lead device
What this could lead to
If it works, this could point toward a way to improve arm and hand function after spinal cord injury, helping with daily tasks like eating and dressing.
What could go wrong
This is a very small, early-stage study with only 12 people. The device is not yet approved for this use, and results may not apply to everyone. There are also risks from the surgical 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

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

About 12 people

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

Started

Aug 2024

Expected to finish

Jan 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

22 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * All participants must provide a signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female aged 22 - 65 years old. * Must provide documentation from personal primary treating physician that reports stable medical condition. * Able to passively range bilateral upper extremities within normal mobility parameters including: * greater than 90 degrees of shoulder flexion and 20 degrees of shoulder extension; * greater than 120 degrees of elbow flexion and reach elbow extension of approximately 150 degrees; * neutral wrist position reaching a minimum of 70 degrees of movement (between flexion and extension; * ability to passively flex and extend fingers. * Maintain current oral anti-spasticity regimen/dosage as approved by study physician with no change in regular use that may affect study outcomes. * Six (6) months to 20 years post spinal cord injury. * Non-progressive spinal cord injury. * Chronic SCI with neurologic level of injury as defined by ISNCSCI AIS A, B, or C. * Neurological level of injury above T2. * Eligible for fMRI per safety questionnaire. * Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study. Exclusion Criteria: * Currently involved in another rehabilitation training study. * Lower motor neuron injury revealed in the upper limbs. * Stabilization hardware in the cervical spine, preventing implantation of ESS system. * Active pressure sores, wounds, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including contractures in the upper and lower extremities). * Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: ventilator dependence, cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing). * Intrathecal baclofen pump therapy for spasticity. * Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months which would result in absence of muscle tone and thus preclude response to electrical stimulation therapy. * Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities). * Clinically significant depression, psychiatric disorders, or ongoing drug abuse. * Any reason the PI or treating physician may deem as harmful to the participant or inappropriate for the participant to enroll or continue in the study. * Body Mass Index (BMI) over 30. * 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The Methodist Hospital Research Institute

    RECRUITING

    Houston, Texas, 77030, United States

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