This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 3 of 7 for:    EPIONE

Use of Hand Prosthesis With Surface Electrical Stimulation for Treatment of Phantom Limb Pain (EPIONE)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Prof. Wassim Raffoul, University of Lausanne Hospitals
Sponsor:
Collaborators:
Aalborg Universitetshospital
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
ClinicalTrials.gov Identifier:
NCT02569918
First received: October 6, 2015
Last updated: January 9, 2017
Last verified: January 2017
  Purpose

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 non-invasive sensory feedback (i.e. surface electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.


Condition Intervention
Phantom Limb Pain Device: Surface electrical stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Natural Sensory Feedback for Phantom Limb Modulation and Therapy

Further study details as provided by Prof. Wassim Raffoul, University of Lausanne Hospitals:

Primary Outcome Measures:
  • Phantom limb pain [ Time Frame: Change in phantom limb pain perception between baseline measurements and 3 months ]
    The pain intensity will be assessed using visual analog scale (VAS)

  • Cortical reorganization [ Time Frame: Change in cortical reorganization between baseline measurements and 3 months ]
    The cortical response to peripheral stimulation will be tracked using MRI


Secondary Outcome Measures:
  • Phantom limb pain [ Time Frame: Change in neuropathic pain symptoms between baseline measurements and 3 months ]
    The pain symptoms wil be assessed using the neuropathic pain symptom inventory (NPSI)

  • Cortical reorganization [ Time Frame: Change in in cortical reorganization between baseline measurements and 3 months ]
    The cortical response to peripheral stimulation will be tracked using EEG


Estimated Enrollment: 20
Study Start Date: February 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surface electrical stimulation
Operation of hand prosthesis with surface electrical sensory feedback
Device: Surface electrical stimulation
Surface electrical stimulation using the following experimental devices. 1) The CE-approved HASOMED electrical isolated stimulator (Rehastim). 2) Two hand prosthesis: the robotic hand "Azzurra" (Prensilia, Italy) and the robotic hand "Multi-sensory Prosthetic Hand" (Wessling robotics, Germany) 3) The EPIONE Psychophysical Testing Platform software for stimulator control. Surface stimulation therapy is provided while providing visual guidance to the subject.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Amputation or peripheral nerve damage of an upper limb.
  • Injury should be in the chronic, stable phase, such that any traumatic injuries or surgical wounds have healed and the person apart from eventual phantom pain (PLP) is healthy and able to carry out experiment.
  • Other treatments for PLP tried with poor results.
  • Patient accepts the study protocol as explained by the physician.
  • The subject experienced intractable PLP (i.e. pain in the denervated or missing extremity) of more than 6 on numerical rating scale (NRS) or visual analog scale (VAS) (0-10 scale). The frequency of PLP episodes presents more than once a week.
  • Amputee subjects without PLP are eligible for part of the study that targets the sensory feedback induction within advanced bidirectional prosthesis control.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02569918

Contacts
Contact: Lee-Ann Laurent Applegate, Professor +41 21 314 35 10 Lee.Laurent-Applegate@chuv.ch
Contact: Marjorie Flahaut, PhD +41 21 314 69 28 Marjorie.Flahaut@chuv.ch

Locations
Switzerland
University of Lausanne Hospital CHUV Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Lee-Ann Laurent-Applegate, Professor    +41 21 314 35 10    Lee.Laurent-Applegate@chuv.ch   
Contact: Marjorie Flahaut, PhD    +41 21 314 69 28    Marjorie.Flahaut@chuv.ch   
Principal Investigator: Wassim Raffoul, Professor         
Sponsors and Collaborators
Prof. Wassim Raffoul
Aalborg Universitetshospital
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
Principal Investigator: Wassim Raffoul, Professor University of Lausanne Hospitals
  More Information

Additional Information:
Responsible Party: Prof. Wassim Raffoul, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02569918     History of Changes
Other Study ID Numbers: EPIONE-602547-4
602547 ( Other Grant/Funding Number: FP7-HEALTH-2013-INNOVATION )
Study First Received: October 6, 2015
Last Updated: January 9, 2017

Keywords provided by Prof. Wassim Raffoul, University of Lausanne Hospitals:
Neuroplasticity
Sensory Feedback
Transcutaneous electrical stimulation
Robotic hand

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

ClinicalTrials.gov processed this record on June 22, 2017