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Could a nerve implant boost hand recovery after spinal injury?

NCT ID NCT05601661

Disease control Sponsor: The University of Texas Health Science Center, Houston Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This small pilot study tested whether pairing vagus nerve stimulation with rehabilitation is safe and feasible for people with cervical spinal cord injury. Six participants received an implanted nerve stimulator and underwent rehab sessions. The study focused on safety and whether people could complete the program, with early looks at hand and arm function.

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 device (Vivistim System)
What this could lead to
If it works, this could point toward a way to improve hand and arm function in people with spinal cord injury.
What could go wrong
This is a very small pilot study with only 6 participants, so results may not apply to everyone. The device requires surgery, which carries risks like infection or voice changes.

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

6 people

The number who actually took part.

Started

Jun 2023

Finished

Aug 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 years and older

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: * a diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above) * at least 12 months post-traumatic SCI * demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger) * meet all clinical criteria for the surgical VNS implantation as determined by the PI, neurosurgeon, and anesthesiologist. Exclusion Criteria: * non-traumatic SCI, injury * presence of ongoing dysphasia or aspiration difficulties * evidence of vagus pre-existing vocal cord paralysis as determined with laryngoscopy procedure * participants with prior left-sided anterior cervical surgery who exhibit too much of scar tissue at the surgery site which will be determined by neurosurgeon * concomitant clinically significant brain injury * history of prior injury to a vagus nerve * receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry * other comorbidities or complications that will hinder or contraindicate surgical procedure * medical or mental instability * pregnancy or plans to become pregnant during the study period.

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical spinal cord injury

Contacts and locations

Locations

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

More trials for these conditions

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