Spinal zap aims to give amputees back their sense of touch
NCT ID NCT04547582
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
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4 people
The number who actually took part.
- Started
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May 2021
- Finished
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Jul 2023
- Lead sponsor
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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
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22 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can VR ease phantom limb pain after amputation?