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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217005
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Greta Preatoni, ETH Zurich

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.


Condition or disease Intervention/treatment Phase
Lower Limb Amputation Knee Lower Limb Amputation Above Knee (Injury) Lower Limb Amputation Below Knee (Injury) Diabetic Peripheral Neuropathy Device: Sensory Feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
amputees or diabetics receiving intervention
Device: Sensory Feedback
Subjects will receive a sensory feedback provided by electrical stimulation




Primary Outcome Measures :
  1. Change from baseline in Visual Analogue scale for pain throughout the study [ Time Frame: 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 ]
    Subjects will complete VAS scale to measure pain level (from 0 to 10, 10 is worst pain immaginable)

  2. Change between tasks with sensory feedback and with no sensory feedback in Ground Reaction Forces [ Time Frame: during motor tasks up to 3 weeks ]
    GRF will be assessed during motor perfomances of the subjects

  3. Change between tasks with sensory feedback and with no sensory feedback in Centre of Mass and Pressure [ Time Frame: during motor tasks up to 3 weeks ]
    CoM and CoP will be assessed during motor perfomances of the subjects

  4. Change from baseline and between tasks with sensory feedback and with no sensory feedback in Vo2 consumption [ Time Frame: during motor tasks up to 3 weeks ]
    metabolic consumption is going to be measured with mobile spiroergometry and compared after walking with and without sensory feedback

  5. Change from baseline between tasks with sensory feedback and with no sensory feedback in Embodiment [ Time Frame: immediately after sessions up to 3 weeks ]
    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))

  6. Change between tasks with sensory feedback and with no sensory feedback in Visual Analogue scale for confidence [ Time Frame: immediately after sessions up to three weeks ]
    Subjects will complete VAS scale to measure confidence level (from 0 to 10, where 10 is max confidence)

  7. Change between tasks with sensory feedback and with no sensory feedback in Joint torque [ Time Frame: during motor tasks up to three weeks ]
    kinematic measurement

  8. Change in Proprioceptive drift between different conditions [ Time Frame: Immediately after sessions in Virtual Reality up to three weeks ]
    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.

  9. Change in Telescoping measures between different conditions [ Time Frame: Immediately after sessions in Virtual Reality up to three weeks ]
    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.


Secondary Outcome Measures :
  1. Trinity Amputation and Prosthesis Experiences Scales [ Time Frame: Immediately before intervention ]
    Subjects will fill the TAPES to measure their satisfaction with the prosthesis (Scores range from 5 to 25, with higher scores indicating greater levels of adjustment)

  2. Change in Quality of Life in Neurological Disorders [ Time Frame: one week before first session and one week after last session ]
    QoL will be assessed through questionnaires to see if the intevention had impact on this aspect (All Neuro-QOL banks and scales are scored such that a high score reflects more of what is being measured)

  3. Amputee Mobility Predictor [ Time Frame: Immediately before the intervention ]
    Subjects will perform AMPRO to assess K level (scores range from 0 to 47, correspoding to levels of mobility from 1(K1) to 4(K4), where 4 is the best level of mobility)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217005


Contacts
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Contact: greta preatoni, PhD 766274077 ext 0041 gretapreatoni1@gmail.com
Contact: michele marazzi, PhD 446322840 ext 0041 michele.marazzi@hest.ethz.ch

Locations
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Switzerland
ETH Zurich Recruiting
Zürich, Switzerland, 8006
Contact: Greta Preatoni, PhD    0766274077 ext 0041    gretapreatoni1@gmail.com   
Contact: Michele Marazzi, PhD    +41446322840 ext 0041    michele.marazzi@hest.ethz.ch   
Sponsors and Collaborators
ETH Zurich
Publications:

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Responsible Party: Greta Preatoni, Doctoral fellowship, ETH Zurich
ClinicalTrials.gov Identifier: NCT04217005    
Other Study ID Numbers: 2019-N-97
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Wounds and Injuries
Neuromuscular Diseases
Nervous System Diseases