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Trial record 2 of 7 for:    EPIONE

Surface Electrical Stimulation for Treatment of Phantom Limb Pain (EPIONE)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Winnie Jensen, Aalborg University
Sponsor:
Collaborators:
Aalborg Universitetshospital
University of Lausanne Hospitals
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
Information provided by (Responsible Party):
Winnie Jensen, Aalborg University
ClinicalTrials.gov Identifier:
NCT02488668
First received: June 30, 2015
Last updated: August 9, 2016
Last verified: August 2016
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Sensory Feedback for Phantom Limb Modulation and Therapy

Further study details as provided by Winnie Jensen, Aalborg University:

Primary Outcome Measures:
  • Phantom limb pain [ Time Frame: Change in pain perception over three months ]
    The pain intensity will be assessed using a visual analog scale (VAS)

  • Cortical reorganization [ Time Frame: Change in cortical reorganization over three months ]
    The cortical response to peripheral stimulation will be tracked using MRI


Secondary Outcome Measures:
  • Cortical reorganization [ Time Frame: Change in cortical reorganization over three months ]
    The cortical response to peripheral stimulation will be tracked using EEG

  • Phantom limb pain [ Time Frame: Change in neuropathic pain symptoms over three months ]
    The pain symptoms wil be assessed using the neuropathic pain symptom inventory (NPSI)


Estimated Enrollment: 20
Study Start Date: June 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surface Electrical Stimulation
Please see information under 'Detailed description'
Device: Surface Electrical Stimulation
Surface electrical stimulation using the following devices; 1) INOMED surface stimulator, 2) 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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Amputation of one or both arms below the shoulder level or amputation of one or both legs below hip joint
  • Total or partial peripheral nerve injury (i.e.,under spinal cord level) causing paralysis of the arms or legs
  • Other treatments for phantom limb pain should have been tried with poor results
  • The subject should experience phantom limb pain at a level of 6 or higher measured on on a visual analog scale (VAS) ranging from 0-10
  • Phantom limb pain should be experienced at least once a week
  • The subject should be in a chronic and stable phase, and the stump should have healed
  • The subject should otherwise be healthy and able to carry out the experiment
  • If pain medication is used it will be acceptable that the person continues to use the medication
  • It should, through peripheral electrical stimulation, be possible to apply the relevant phantom emotions to the subject

Exclusion Criteria:

  • Cognitive impairment
  • Pregnancy
  • Prior or current psychological diseases such as borderline, schizophrenia, depression or manic-depressive
  • Acquired brain injury with residual impairment
  • Prior neurological or musculoskeletal diseases
  • History of or active substance abuse disorder
  • Persons with that experience an allergic reaction to surface electrodes
  • Persons with fear for electrical stimulation or pain
  • Persons that are hypersensitive to electrical stimulation and experience the stimulation as unpleasant
  • Persons that feel may claustrophobic in an MRI scanner
  • Persons that have metal parts in the body (such as pacemakers or metal screws)
  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: NCT02488668

Contacts
Contact: Winnie Jensen, Ph.D 0045 99409825 wj@hst.aau.dk
Contact: Romulus Lontis, Ph.D 0045 99402435 lontis@hst.aau.dk

Locations
Denmark
Winnie Jensen Recruiting
Aalborg, Denmark
Sponsors and Collaborators
Winnie Jensen
Aalborg Universitetshospital
University of Lausanne Hospitals
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
Investigators
Principal Investigator: Winnie Jensen, Ph.D Aalborg University
  More Information

Additional Information:
Responsible Party: Winnie Jensen, Professor, Aalborg University
ClinicalTrials.gov Identifier: NCT02488668     History of Changes
Other Study ID Numbers: EPIONE-602547-1
602547 ( Other Grant/Funding Number: FP7-HEALTH-2013-INNOVATION )
Study First Received: June 30, 2015
Last Updated: August 9, 2016

Keywords provided by Winnie Jensen, Aalborg University:
Transcutaneous Electrical Stimulation
Neuroplasticity
Sensory Feedback

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 August 17, 2017