Spinal zap aims to give amputees back their sense of touch

NCT ID NCT04547582

What the study statuses mean

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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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 3 times

Summary

This study tested whether electrical stimulation of the spinal cord could help people with lower-leg amputations feel sensations in their missing limb and reduce phantom limb pain. Researchers implanted small electrodes in the lower back of 4 participants to stimulate spinal nerves. The study was terminated early, so results are limited, but the goal was to improve quality of life and prosthetic use.

What this could mean

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

Active substance
spinal cord stimulator device
What this could lead to
If it works, this could point toward a way to reduce phantom limb pain and improve prosthetic control for amputees.
What could go wrong
This was a very small, early study that was terminated before completion. It is unclear if the approach is safe or effective, and results may not apply to all amputees.

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

4 people

The number who actually took part.

Started

May 2021

Finished

Jul 2023

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 70 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: 1. Subjects must have an amputation of one lower limb, at a level between the ankle and knee joints. Minor amputation of the contralateral limb (i.e. toes or partial foot) is not exclusionary. 2. Subjects must be over 6 months post-amputation at the time of lead placement. 3. Subjects must be between the ages of 22 and 70 years old. Participants outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing. 4. Subjects must have used their current prosthesis for at least 6 months and achieved at least K-1 ambulator status at the time of lead placement, as determined by the Amputee Mobility Predictor. Exclusion Criteria: 1. Subjects must not have any serious disease or disorder that could affect their ability to participate in this study. 2. Female subjects of childbearing age must not be pregnant or breast-feeding. 3. Subjects must not be receiving medications that affect blood coagulation. 4. Subjects must not have an allergy to contrast medium or renal failure that could be exacerbated by the contrast agent used in MRIs. For this study, renal insufficiency will be determined through blood work and defined as BUN of 30 or less and Creatinine of 1.5 or less. 5. Subjects may not have a hemoglobin A1c level above 8.0 mg/dl at time of implant. 6. Subjects may not have any implanted medical devices that are not cleared for MRI. 7. Subjects with a T-Score higher than 63 on the 18-question Brief Symptoms Inventory (BSI-18) who have undergone discussions with and been deemed unsuitable by the Principal Investigator, a study physician, and a psychologist 8. Subjects may not have a cardiac pacemaker. 9. Subjects may not have a cardioverter defibrillator. 10. Subjects may not be currently receiving diathermy therapy. 11. Subjects may not have an implanted infusion pump. 12. Subjects may not be immunosuppressed or currently receiving immunosuppressive medications. 13. Subjects may not have a profession (e.g. radiology technologist) or medical condition (e.g. remissory cancer involved regular follow-up x-rays) that would increase radiation exposure in the 12 months prior to starting or after ending participation in the study.

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Conditions

The condition(s) this trial relates to.

Pain Phantom Limb

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

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