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

NCT07448350 | Recruiting

• 2 other identifiers: SENSE-P_Fit4MedRobPNC0000007
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lower Limb Amputation Above Knee; Lower Limb Amputation Below Knee

Keywords

prosthetics; somatotopic sensations; Transcutaneous Electrical Nerve Stimulation; rehabilitation; sensory feedback restoration

Outcome Measures

Primary Outcomes (1)

• Ad hoc developed psychometric questionnaires

  The primary endpoint of the study will be the change in the phantom limb perception and a modification of post-amputation neuropathic pain between the beginning (T0 at Day 0) and immediately after the intervention (T2 at Day 20). For each delivered stimulus, the patient will be asked to indicate the location of the evoked sensation adopting pictures representing the missing foot and leg and then to describe them. The descriptors included: a five-point scale for the naturalness ranging from unnatural to natural, a metric of the location of the sensation (i.e., superficial and/or deep), a scale from 0 to 10 for the intensity and pain of the sensation and multiple choices for the quality (touch/pression, pinch, vibration, tugging, tingling, burning, hot, cold, ankle flexion, ankle extension, toes flexion, toes extension and nothing).

  At baseline (Day 0) and immediately after the intervention (Day 20)

Secondary Outcomes (5)

• Changes in ambulation performances

  At baseline (Day 0) and immediately after the intervention (Day 20)

• Changes in ambulation performances

  At baseline (Day 0) and immediately after the intervention (Day 20)]

• Changes in ambulation performances

  At baseline (Day 0) and immediately after the intervention (Day 20)]

• Changes in ambulation performance

  At baseline (Day 0) and immediately after the intervention (Day 20)]

• Changes in ambulation performance

  At baseline (Day 0) and immediately after the intervention (Day 20)

Study Arms (1)

TENS Group

EXPERIMENTAL

Other: Transcutaneal Electrical Nerve Stimulation

Interventions

Transcutaneal Electrical Nerve Stimulation OTHER

Each patient will undergo two 60-minute sessions per day, except for the evaluation ones which are expected to last approximately 90 minutes, five days per week for a total duration of 4 weeks. 1. Mapping sessions: Four Mapping sessions performed at the beginning of each week. 2. Stimulus Intensity Discrimination sessions: Three Stimulus Intensity Discrimination sessions will be conducted over three consecutive days during the first week. 3. Rehabilitative sessions: Ten rehabilitative sessions aimed at re-educating walking in controlled and repeatable experimental conditions while simultaneously using the device with either technological solutions or proprioceptive exercises will be carried out. 4. Evaluation sessions: Three evaluation sessions will be performed at the beginning (T0), in the middle (T1) and at the end (T2) of the experimental protocol.

TENS Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (1)

Don Gnocchi Foundation

Rome, Rome, 00168, Italy

RECRUITING

Related Publications (1)

• Demofonti A, Germanotta M, Zingaro A, Bailo G, Insalaco S, Cordella F, Aprile IG, Zollo L. Restoring Somatotopic Sensory Feedback in Lower Limb Amputees through Noninvasive Nerve Stimulation. Cyborg Bionic Syst. 2025 Apr 29;6:0243. doi: 10.34133/cbsystems.0243. eCollection 2025.

  PMID: 40302942 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: March 4, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)