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Direct Nerve Stimulation for Treatment of Phantom Limb Pain (EPIONE)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Aalborg Universitetshospital
Sponsor:
Collaborators:
Aalborg University
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):
Aalborg Universitetshospital
ClinicalTrials.gov Identifier:
NCT02493842
First received: June 22, 2015
Last updated: August 8, 2016
Last verified: August 2016
  Purpose

Background:

Phantom limb pain (PLP) develops in 50-80% of subjects who have a limb amputated. It is not well known what causes PLP to develop and the current treatments have been shown to be largely ineffective. Resent research, however, have indicated that cortical reorganizing occurring after amputation of the cortex areas related to the missing limb may be related to the development of PLP. Furthermore, the research indicated that by providing meaningful sensory input coming from the phantom limb the PLP may be alleviated and the cortical organization normalized.

Aim:

The CIP described in the current application, is part of a the EU-project "EPIONE", which aims to investigate if and how cortical normalization and PLP alleviation can be induced by providing phantom limb sensations (sensations which seems to originate from the missing limb) in hand amputated subjects.

Method:

In the current study, which will take place at Aalborg University Hospital (AUH), 2-4 hand amputated subjects experiencing severe PLP will implanted with interneural nerve electrodes in the arm stump for up to one year.

Therapy will be evaluated in two stages, first during a standardized four week phase where the subject receives daily therapy. If the therapy is shown to be effective, therapy may be reinitiated during a second longer therapy phase.

During the therapy sessions, selective nerve stimulation will be performed. The amputee will experience this as sensations (movement, touch, temperature, vibration etc.) originating from the phantom limb. While implanted, we will investigate how well we can induce these sensations and we will provide a stimulation therapy, which consist of stimulation activities which requires the subject to focus on the evoked sensations. Prior to, during a and following therapy a series of assessments (standardized across all EPIONE partners to enable comparison) will be conducted to relate therapy with PLP, cortical organization, the mental state etc. of the subject.

Expected outcome:

The stimulation therapy is expected to alleviate PLP and induce cortical normalization. The experience we gain might be used for deriving clinical guidelines on how to treat PLP.


Condition Intervention
Phantom Limb Pain Device: Transverse Intrafasicular Multichannel electrode (TIME)

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 Aalborg Universitetshospital:

Primary Outcome Measures:
  • Phantom limb pain [ Time Frame: Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment) ]
    The pain intensity will be assessed using a visual analog scale (VAS) analog scale (VAS), the neuropatic pain sympton inventory (NPSI), the brief pain inventory interference scale (BPSI)

  • Cortical reorganization [ Time Frame: Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment) ]
    The cortical response to peripheral stimulation will be tracked using MRI MRI and EEG.


Secondary Outcome Measures:
  • Cortical reorganization [ Time Frame: Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment) ]
    The cortical response to peripheral stimulation will be tracked using EEG

  • Phantom limb pain [ Time Frame: Change in pain perception over 3 -15 months. (Time frame is dependent on effect of treatment) ]
    The pain symptoms wil be assessed using the neuropatic pain symptom inventory (NPSI)


Estimated Enrollment: 4
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: Invasive nerve stimulation

Invasive nerve stimulation using the following experimental devices

  1. Transverse Intrafascicular Multichannel Electrode for human (TIME-4H)
  2. The STIMEP stimulator
  3. The EPIONE Psychophysical Testing Platform software for stimulator control

Nerve stimulation therapy is provided while providing visual guidance to the subject and without the use of hand prosthetic devices

Device: Transverse Intrafasicular Multichannel electrode (TIME)
Peripheral nerve stimulation is conducted with Transverse Intrafasicular Multichannel electrode (TIME) version 4 electrodes to induce sensory sensations from the phantom hand, while subject is virtualizing a movement or event which may cause the specific sensation.

  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:

  • Adult man or woman >18 yrs and < 70 yrs.
  • Unilateral transradial amputation.
  • Other treatments for PLP tried with poor results
  • Patient accepts the study protocol as explained by the physician.
  • The subject must experience intractable PLP higher than 6 on a Visual Analog Scale (VAS) from 0-10. 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 experiencing phantom pain is healthy and able to carry out the experiment.

Exclusion Criteria:

  • Cognitive impairment
  • Current or prior psychological impairments: major personality disturbance (i.e., borderline, antisocial), major depression, bipolar I.
  • Pregnant (if fertile woman: assessed via a pregnancy test) or not using contraception accepted by the authorities during the study
  • Breastfeeding women cannot participate in the study
  • History of or active substance abuse disorder.
  • Acquired brain injury with residual impairment
  • Intellectual Disability (IQ < 70)
  • Current or prior neurological or musculoskeletal disease
  • Current or prior dermatological conditions
  • Persons with other diseases that may affect the function of the nervous system, e.g., diabetes, HIV or renal failure.
  • Subjects who will not be able to have an fMRI examination conducted because of metal implants such as: pacemakers, artificial joints, bone screws.
  • Subjects who suffer from claustrophobia and who are unable of having an fMRI examination conducted (the examination requires the subject to lie inside a narrow space in the MRI machine).
  • Subjects cannot participate in other clinical studies and/or tests of medical devices
  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: NCT02493842

Contacts
Contact: Preben Sørensen, MD 97660000 ext +45 prebsoe@rn.dk
Contact: Kristian R Harreby, PhD 99407520 ext +45 krauhe@hst.aau.dk

Locations
Denmark
Aalborg University Hospital Recruiting
Aalborg, Nordjylland, Denmark, 9000
Contact: Preben Sørensen, MD    97660000 ext +45    prebsoe@rn.dk   
Contact: Kristian R Harreby, PhD    99407520 ext +45    krauhe@hst.aau.dk   
Sponsors and Collaborators
Aalborg Universitetshospital
Aalborg University
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: Preben Sørensen, MD Aalborg Universitetshospital
  More Information

Additional Information:
Responsible Party: Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT02493842     History of Changes
Other Study ID Numbers: EPIONE-602547-5
no. 602547 ( Other Grant/Funding Number: FP7-HEALTH-2013-INNOVATION )
Study First Received: June 22, 2015
Last Updated: August 8, 2016

Keywords provided by Aalborg Universitetshospital:
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

ClinicalTrials.gov processed this record on September 19, 2017