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

NCT04217005 | Recruiting

• 1 other identifier: 2019-N-97
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (9)

• Change from baseline in Visual Analogue scale for pain throughout the study

  Subjects will complete VAS scale to measure pain level (from 0 to 10, 10 is worst pain immaginable)

  one month before the study, 2 weeks before the study, immediately before the intervention, immediately after the intervento, after tasks with and without sensory feedback, 2 weeks after last intervention, 1 month after last intervention

• Change between tasks with sensory feedback and with no sensory feedback in Ground Reaction Forces

  GRF will be assessed during motor perfomances of the subjects

  during motor tasks up to 3 weeks

• Change between tasks with sensory feedback and with no sensory feedback in Centre of Mass and Pressure

  CoM and CoP will be assessed during motor perfomances of the subjects

  during motor tasks up to 3 weeks

• Change from baseline and between tasks with sensory feedback and with no sensory feedback in Vo2 consumption

  metabolic consumption is going to be measured with mobile spiroergometry and compared after walking with and without sensory feedback

  during motor tasks up to 3 weeks

• Change from baseline between tasks with sensory feedback and with no sensory feedback in Embodiment

  Embodiment will be measured with questionnaires (from -3 to +3, +3 totally agrees; two questions are from 1 to 10 (to measure vividness, where 10 is max vividness) and from 1 to 100 (to measure prevalence, where 100 is max duration of the embodiment feeling))

  immediately after sessions up to 3 weeks

• Change between tasks with sensory feedback and with no sensory feedback in Visual Analogue scale for confidence

  Subjects will complete VAS scale to measure confidence level (from 0 to 10, where 10 is max confidence)

  immediately after sessions up to three weeks

• Change between tasks with sensory feedback and with no sensory feedback in Joint torque

  kinematic measurement

  during motor tasks up to three weeks

• Change in Proprioceptive drift between different conditions

  To measure embodiment subjects will be asked after VR sessions to indicate where they feel their leg without looking at the limb in real world. This is a measure of embodiment.

  Immediately after sessions in Virtual Reality up to three weeks

• Change in Telescoping measures between different conditions

  To measure embodiment subjects will be asked after VR sessions to indicate how long they feel their leg without looking at the limb in real world. This is a measure of embodiment.

  Immediately after sessions in Virtual Reality up to three weeks

Secondary Outcomes (3)

• Trinity Amputation and Prosthesis Experiences Scales

  Immediately before intervention

• Change in Quality of Life in Neurological Disorders

  one week before first session and one week after last session

• Amputee Mobility Predictor

  Immediately before the intervention

Study Arms (1)

experimental group

EXPERIMENTAL

amputees or diabetics receiving intervention

Device: Sensory Feedback

Interventions

Sensory Feedback DEVICE

Subjects will receive a sensory feedback provided by electrical stimulation

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• transfemoral amputation or transtibial amputation or knee disarticulation or diabetic peripheral neuropathy
• the subject should be healthy other than the amputation and the diabetic neuropathy and in the range of 18-70 years old
• the subject should be able to comfortably walk, sit and stand alone

You may not qualify if:

• cognitive impairment
• pregnancy
• Prior or current psychological diseases such as borderline, schizophrenia, Depression or Maniac Depression
• acquired brain injury with residual impairment
• excessive sensitivity or pain to electrical stimulation with surface electrodes
• cybersickness

Sponsors & Collaborators

• ETH Zurich: lead

Study Sites (1)

ETH Zurich

Zurich, 8006, Switzerland

RECRUITING

Related Publications (23)

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• Borda L, Gozzi N, Preatoni G, Valle G, Raspopovic S. Automated calibration of somatosensory stimulation using reinforcement learning. J Neuroeng Rehabil. 2023 Sep 26;20(1):131. doi: 10.1186/s12984-023-01246-0.

  PMID: 37752607 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

greta preatoni, PhD

CONTACT

766274077; gretapreatoni1@gmail.com

michele marazzi, PhD

CONTACT

446322840; michele.marazzi@hest.ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral fellowship

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: January 3, 2020
• Study Start: December 13, 2019
• Primary Completion: December 15, 2025
• Study Completion: January 15, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)