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Could a zapping device boost arm recovery in spinal injury?

NCT ID NCT04288245

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a device that stimulates the vagus nerve during arm rehabilitation exercises to see if it helps people with spinal cord injuries regain upper limb function. Twenty adults with chronic cervical spinal cord injury will receive either active or placebo stimulation during therapy sessions. The main goal is to check safety, with a secondary look at whether the device is practical and potentially effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vagus nerve stimulation (VNS) device
What this could lead to
If it works, this could point toward a new way to improve arm and hand function after spinal cord injury by pairing nerve stimulation with rehabilitation.
What could go wrong
This is a small, early safety study with only 20 participants. The device may not provide meaningful benefit, and risks from nerve stimulation are still being assessed.

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 20 people

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

Started

Feb 2021

Expected to finish

Sep 2026

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

18 to 64 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 In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Adult, aged 18-64 * In good general health as evidenced by medical history and diagnosed with first time cervical spinal cord injury resulting in an ASIA grade B, C, or D, and level 1 or better motor function as described by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). * SCI caused by trauma that occurred ≥ 12 months prior to enrollment * Meets all clinical criteria for the surgical VNS implantation as determined by the PI, surgeon, and anesthesiologist * Must demonstrate some residual upper limb and hand movement in either arm * Appropriate candidate for VNS implantation * Willing and able to comply with the study protocol Exclusion Criteria An individual who meets any of the following criteria will be excluded from participation in this study: * Spinal cord injuries by sharp objects, firearms, and non-traumatic or congenital causes, even if at different levels of the spinal cord * Any evidence of recurrent laryngeal nerve injury (Evident during required laryngoscopy for all participants with Prior right-sided anterior cervical surgery- done prior to randomization) * Excessive scar tissue marking implantation unsafe (evident at surgery) * Concomitant clinically significant brain injuries * Prior injury to vagus nerve * Prior or current treatment with vagus nerve stimulation * Participant receiving any therapy (medication or otherwise) that would interfere with VNS * Pregnancy or lactation * Clinical complications that hinder or contraindicate the surgical procedure * Psychiatric disorders, psychosocial, and/or cognitive impairment that would interfere with study participation, as assessed by medical evaluation * Abusive use of alcohol and/or illegal substances use * Participation in other interventional clinical trial * Participants with known immunodeficiency including participants who are receiving or have received chronic corticosteroids, immunosuppressants, immunostimulating agents or radiation therapy within 6 months * Significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.). * Active neoplastic disease. * Participants with significant local circulatory problems, (e.g. thrombophlebitis and lymphedema). * Participants with any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator, including systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the participant unable to perform appropriate postoperative rehabilitation. * Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance. * Aphasia and other cognitive deficits that make understanding the potential risks and benefits of the study impossible for participant. Inability to personally provide informed consent. * A recent history of syncope * A recent history of dysphagia * Currently require, or are likely to require diathermy * Significant respiratory issues that would interfere with participation * Non-English speaking * Patients who are acutely suicidal and/or have been admitted for a suicide attempt * Incarceration or legal detention

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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

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

More trials for these conditions

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