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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02519907
First Posted: August 11, 2015
Last Update Posted: August 28, 2017
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. Read our disclaimer for details.
Collaborators:
Aalborg University
Aalborg Universitetshospital
University of Lausanne Hospitals
Université Montpellier
Lund University
Novosense AB
Mxm-Obelia
Ecole Polytechnique Fédérale de Lausanne
Universitat Autonoma de Barcelona
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Ken Yoshida, Indiana University
  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 Ken Yoshida, Indiana University:

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

  • Cortical reorganization [ Time Frame: Change in pain perception from baseline to three 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 from baseline to three months ]
    The pain symptoms will be assessed using the neuropathic pain symptom inventory (NPSI)


Enrollment: 6
Study Start Date: September 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
Please see information under 'Detailed description'
Device: Surface Electrical Stimulation
Please see information under 'Detailed description'

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult man or woman >18 yrs and < 75 yrs.
  • Unilateral transradial, transhumeral, transfemoral, or transtibial .
  • Other treatments for PLP tried with poor results.
  • Reading ability is adequate to independently complete study questionnaires.
  • Subject accepts the study protocol as explained by the investigator.
  • No anticipated changes in psychoactive medications over the course of the study; subject agrees to alert study staff if unanticipated medication changes are required during the study.
  • The subject must experience intractable PLP equal to or greater than 6 on Visual Analogue Scale for Pain (VAS; 0-10 analogue scale).
  • The frequency of PLP attacks must present itself more than once a week.
  • Amputation should be in the chronic, stable phase, such that the stump has healed and the person apart from phantom pain, is healthy and able to carry out the experiment

Exclusion Criteria:

  • Severe cognitive impairment as indicated by IQ <70
  • Current or prior psychological impairments: Major personality disturbance (i.e. borderline, antisocial), Major depression, Bipolar I, schizophrenia
  • Pregnancy
  • History of or active substance abuse disorder
  • Acquired brain injury with residual impairment that would interfere with participation in the trial
  • Prior neurological or musculoskeletal disease that would interfere with participation in the trial
  • Current or prior dermatological conditions that would interfere with participation in the trial
  • Excessive sensitivity to electrical stimulation with surface electrode.
  • Interfering anxiety about electrical stimulation or pain.
  • Persons with other diseases that may affect the function of the nervous system. (eg, diabetes, HIV, renal failure)
  • Persons with an implantable stimulator such as a pacemaker or any type of metallic shrapnel, object or device.
  • History of claustrophobia, obesity, or other condition that interferes with the fMRI
  Contacts and Locations
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): NCT02519907


Locations
United States, Indiana
IU Health Neuroscience Center
Indianapolis, Indiana, United States, 46202
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, United States, 46254
Sponsors and Collaborators
Indiana University
Aalborg University
Aalborg Universitetshospital
University of Lausanne Hospitals
Université Montpellier
Lund University
Novosense AB
Mxm-Obelia
Ecole Polytechnique Fédérale de Lausanne
Universitat Autonoma de Barcelona
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Ken Yoshida, PhD Indiana University
  More Information

Additional Information:
Responsible Party: Ken Yoshida, Associate Professor, Department of Biomedical Engineering, Indiana University
ClinicalTrials.gov Identifier: NCT02519907     History of Changes
Other Study ID Numbers: EPIONE-602547-2
602547 ( Other Grant/Funding Number: FP7-HEALTH-2013-INNOVATION )
First Submitted: July 30, 2015
First Posted: August 11, 2015
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Ken Yoshida, Indiana University:
Nerve 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