NCT04217005

Enhancing Abilities in Amputees and Patients With Peripheral Neuropathy Through Restoration of Sensory Feedback

Enhancing Functional and Cognitive Performances in People With Amputation and Peripheral Neuropathy Through the Restoration of Sensory Feedback in Real World and Virtual Reality Environments

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: ETH Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Many amputees suffer from Phantom Limb Pain (PLP), a condition where painful perceptions arise from the missing limb. Leg amputees wear prostheses that do not provide any sensory feedback, apart from the stump-socket interaction. Increased physical effort associated with prosthesis use as well as discomfort often lead to rejection of artificial limbs. Additionally, the perception of the missing limb and its brain representation, do not match-up with what amputees see (the prosthesis) and this is made worse by the absence of sensory feedback. Therefore, re-establishing the sensory flow of information between the subject's brain and the prosthetic device is extremely important to avoid this mismatch, which creates inadequate embodiment. This study focuses on improving functional abilities and decreasing PLP in amputees thanks to the use of a system able to generate a sensory feedback (SF), which will be provided with a non-invasive electrical stimulation (ES). First, the possibility of enhancing the performance in different functional tasks thanks to the use of SF will be explored. Furthermore, it will be evaluated if SF enhances the prosthesis embodiment and helps restoring a multisensory integration (visuo-tactile), potentially providing also a pain relief. Once tested this system on amputees, also people with peripheral neuropathy and sensory loss will be recruited. Diabetic patients can suffer from symmetrical polyneuropathy (DSPN), which is a common complication caused by prolonged glucose unbalanced levels that lead to nerve damage. Non-invasive ES has been proposed and used as a therapy to treat the chronic pain conditions. In particular, TENS (transcutaneous electrical nerve stimulation) is a type of non-invasive ES, which is able to activate large diameter afferent fibers. The gate control theory of pain states that these large diameter fibers inhibit central nociceptive transmission with a resultant decrease in pain perception. Therefore, also these patients will be recruited to see whether adding a non-invasive SF can enhance their functional motor abilities while diminishing their pain. The subjects will perform a pool of the following tasks, depending on their residual abilities: motor tasks (walking on ground level and on stairs), cognitive tasks (dual tasks), subjective evaluation of prosthesis weight and description of sensations from ES. Some tasks will be performed in Virtual Reality environments with and without an active stimulation.

Conditions

• Lower Limb Amputation Knee
• Lower Limb Amputation Above Knee (Injury)
• Lower Limb Amputation Below Knee (Injury)
• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Sensory Feedback	Subjects will receive a sensory feedback provided by electrical stimulation

Timeline

• Start date: 2019-12-13
• Primary completion: 2025-12-15
• Completion: 2026-01-15
• First posted: 2020-01-03
• Last updated: 2024-02-20

Locations

1 site across 1 country: Switzerland