Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07448350

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

Led by Campus Bio-Medico University · Updated on 2026-05-13

15

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

Sponsors

C

Campus Bio-Medico University

Lead Sponsor

F

Fondazione Don Carlo Gnocchi Onlus

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Unilateral transtibial or transfemoral amputation at least two months prior to the study
  • Stable clinical conditions
  • Intact skin on the residual limb
  • No cognitive deficits
  • Able to walk using a prosthesis
  • No previous experience with TENS treatment
Not Eligible

You will not qualify if you...

  • Bilateral lower limb amputation
  • Open wounds or sores on the residual limb
  • Cognitive deficits
  • Pregnancy
  • Presence of implanted medical devices (e.g., cardiac defibrillators, pacemakers, infusion pumps)
  • Refusal to sign the informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Don Gnocchi Foundation

Rome, Rome, Italy, 00168

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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