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Use of Hand Prosthesis With Direct Nerve Stimulation for Treatment of Phantom Limb Pain (EPIONE)

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ClinicalTrials.gov Identifier: NCT02796495
Recruitment Status : Withdrawn (Study has been completed in terms of duration but no patient has been recruited during this time)
First Posted : June 10, 2016
Last Update Posted : November 14, 2017
Sponsor:
Collaborators:
Aalborg University Hospital
University of Freiburg
Université Montpellier
Lund University
Indiana University School of Medicine
Novosense AB
Mxm-Obelia
Ecole Polytechnique Fédérale de Lausanne
Universitat Autonoma de Barcelona
Catholic University of the Sacred Heart
Aalborg University
Information provided by (Responsible Party):
Prof. Wassim Raffoul, University of Lausanne Hospitals

Brief Summary:

Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously difficult to treat. Amputation usually follows traumatic injuries or surgery following vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is required for the survival of the patient. The loss of a limb or other body parts is usually followed by the sensation that the lost body part is still present and can be felt. These phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well known that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic, psychological and other, are ineffective.

Today it is believed that phantom limb pain may be related to changes in the cortex of the brain. There is evidence that these changes may be modulated - or even reversed - by providing sensory input to the stump or amputation zone. For example, cortical reorganization and alleviation of phantom limb pain has been observed in amputees following intense use of a hand prosthesis. However, there is no consistent knowledge on which type of peripheral sensory feedback may be effective in affecting the cortical plasticity or on how to best apply the sensory feedback.

The aim of the proposed research is to create natural, meaningful sensations through providing invasive sensory feedback (i.e. electrical stimulation through intraneural implantation of electrodes) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.


Condition or disease Intervention/treatment Phase
Phantom Limb Pain Device: Operation of hand prosthesis with direct nerve stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Sensory Feedback for Phantom Limb Modulation and Therapy
Study Start Date : May 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Operation of hand prosthesis with direct nerve stimulation

A system composed by the integration of the following non-CE marked medical devices specifically designed for the study will be used in one or two amputees:

  • STIMEP (multichannel electrical stimulator for the peripheral nervous system; AXONIC)
  • TIME-4H Intraneural Electrodes (ALBERT-LUDWIGS-UNIVERSITAET FREIBURG)
  • Sensorized Hand Prosthetics for amputees IH2 Prosthetic Azurra Prensilia (Prensilia Ltd.)
  • Prosthetics sensorized hand for amputees DLR/HIT Hand II (Wessling Robotics)
  • ODROID software integration within the afferent and efferent bi-directional control of the robotic hand
  • The EPIONE Psychophysical Testing Platform software for stimulator control
Device: Operation of hand prosthesis with direct nerve stimulation

Four TIME-4H electrodes will be implanted in the median and ulnar nerves of the amputees. The electrodes will be connected with the STIMEP electrical multichannel stimulator. The stimulator will be connected with one of the two sensorized hand prosthesis. Afferent and efferent signals will be elaborated and integrated by the ODROID software.

The amputees will be able to control the prosthetic hand movement and receive a sensory feedback from the prosthesis sensors.

The use of the prosthesis during different tasks will be considered the intervention.





Primary Outcome Measures :
  1. Phantom limb pain (questionnaires) [ Time Frame: Change in phantom limb pain perception during the all study (from baseline to maximum 6 months) ]
    The pain intensity will be assessed using visual analog scale (VAS)

  2. Cortical reorganization (fMRI) [ Time Frame: Change in cortical reorganization before and at the end of treatment (from baseline to maximum 6 months) ]
    The cortical response to peripheral stimulation will be tracked using fMRI


Secondary Outcome Measures :
  1. Phantom limb pain (questionnaires) [ Time Frame: Change in neuropathic pain symptoms during the all study (from baseline to maximum 6 months) ]
    The pain symptoms will be assessed using the Neuropathic Pain Symptom Inventory (NPSI)

  2. Cortical reorganization (EEG) [ Time Frame: Change in cortical reorganization before and at the end of treatment (from baseline to maximum 6 months) ]
    The cortical response to peripheral stimulation will be tracked using EEG



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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:

  • Unilateral transradial amputation.
  • Amputation should be in the chronic, stable phase, such that the stump has healed and the person apart from eventual phantom pain (PLP) is healthy and able to carry out experiments.
  • Other treatments for PLP tried with poor results.
  • Patient accepts the study protocol as explained by the physician.
  • The subject experienced intractable PLP of more than 6 on NRS or VAS (0-10 scale). The frequency of PLP episodes presents more than once a week.

Exclusion Criteria:

  • Cognitive impairment
  • Current or prior psychological impairments: Major personality disturbance (i.e. borderline, antisocial), Major depression, Bipolar I.
  • Pregnancy
  • History of or active substance abuse disorder
  • Acquired brain injury with residual impairment
  • Intellectual Disability (IQ < 70)
  • Prior neurological or musculoskeletal disease
  • Current or prior dermatological conditions
  • Excessive sensitivity to electrical stimulation with surface electrodes. People afraid of electrical stimulation or pain.
  • People with other diseases which may affect the function of the nervous system. (Diabetes, HIV, Renal Failure)
  • Patients implanted with pacemakers

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): NCT02796495


Locations
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Switzerland
University of Lausanne Hospital CHUV
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Prof. Wassim Raffoul
Aalborg University Hospital
University of Freiburg
Université Montpellier
Lund University
Indiana University School of Medicine
Novosense AB
Mxm-Obelia
Ecole Polytechnique Fédérale de Lausanne
Universitat Autonoma de Barcelona
Catholic University of the Sacred Heart
Aalborg University
Investigators
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Principal Investigator: Wassim Raffoul, Professor University Hospital Lausanne CHUV

Additional Information:
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Responsible Party: Prof. Wassim Raffoul, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02796495     History of Changes
Other Study ID Numbers: EPIONE-602547-7
602547 ( Other Grant/Funding Number: FP7-HEALTH-2013-INNOVATION )
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The laws on protection and data sharing is currently being analysed by one of the consortium partners

Keywords provided by Prof. Wassim Raffoul, University of Lausanne Hospitals:
Neuroplasticity
Sensory Feedback
Nerve stimulation
Robotic Hand

Additional relevant MeSH terms:
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Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain