TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception

The aim of the study is to evaluate the changes induced by a course of Transcutaneous Electrical Nerve Stimulation (TENS) treatment on the perception of phantom limb pain. In particular, we want to evaluate the changes induced by a course of TENS treatment on posture, balance, and gait. For each patient, the study will consist of a total of 20 sessions (4 mapping sessions, 3 Stimulus Intensity Discrimination sessions, 10 rehabilitation treatments, and 3 evaluation sessions). One session will be carried out each day. Each session will last 60 minutes, except for the evaluation sessions, which are expected to last approximately 90 minutes. For the patient, the study ends with the last evaluation, voluntary withdrawal from the study, or the patient's death.

NCT Number	NCT07448350
Lead Sponsor	Campus Bio-Medico University Collaborators: Fondazione Don Carlo Gnocchi ETS
Conditions	Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Enrollment	15 participants
Start Date	2026-05-05
Primary Completion	2027-10-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-13