Using TENS to restore localized limb sensations and improve phantom limb perception after above- or below-knee amputation
Transcutaneous Electrical Nerve Stimulation for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
This program tests whether a four-week course of transcutaneous electrical nerve stimulation (TENS) combined with conventional rehabilitation can restore somatotopic sensations and improve phantom limb perception in adults with a single above- or below-knee amputation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Campus Bio-Medico University Academic / other |
| Locations | 1 site (Rome, Rome) |
| Trial ID | NCT07448350 on ClinicalTrials.gov |
What this trial studies
Adults with unilateral transtibial or transfemoral amputation receive a four-week, clinic-based program combining TENS and conventional rehabilitation delivered five days per week. Sessions include repeated sensory mapping to locate optimal electrode positions over the tibial or sciatic nerve, stimulus intensity discrimination training, and rehabilitation treatments, with evaluation sessions spaced through the course. Most sessions last about 60 minutes and evaluation sessions about 90 minutes, and all enrolled participants receive the same intervention (no randomization). The aim is to track changes in phantom limb perception, posture, balance, and gait following the TENS-enhanced rehabilitation program.
Who should consider this trial
Good fit: Adults aged 18–80 with a single above- or below-knee amputation at least two months earlier, stable clinical status, intact residual-limb skin, able to walk with a prosthesis, cognitively intact, and with no prior TENS experience are ideal candidates.
Not a fit: People with bilateral amputation, open wounds on the residual limb, implanted electronic medical devices, pregnancy, significant cognitive deficits, or who cannot walk with a prosthesis are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could restore more natural, localized limb sensations, reduce phantom limb discomfort, and improve posture, balance, and walking function.
How similar studies have performed: Small clinical reports and prior peripheral nerve stimulation studies have shown reductions in phantom pain and altered sensation, but restoring precise somatotopic sensory feedback in lower-limb amputees remains relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 80 years; * unilateral TTA or TFA at least two months prior the study; * stable clinical conditions; * skin integrity; * absence of cognitive deficits; * able to walk using the prosthesis; * no previous experience with TENS. Exclusion Criteria: * Bilateral amputation; * open wounds or sores on the residual limb; * cognitive deficits; * pregnancy; * presence of implanted medical device (e.g., cardiac defibrillators, pacemakers or infusion pumps); * refusal to sign the informed consent.
Where this trial is running
Rome, Rome
- Don Gnocchi Foundation — Rome, Rome, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.