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Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis (EPIONE)

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ClinicalTrials.gov Identifier: NCT02589080
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : August 17, 2018
Sponsor:
Collaborators:
Aalborg Universitetshospital
University of Freiburg
Université Montpellier
Indiana University School of Medicine
Ecole Polytechnique Fédérale de Lausanne
Universitat Autonoma de Barcelona
Catholic University of the Sacred Heart
Aalborg University
Information provided by (Responsible Party):
Goran Lundborg, Lund University Hospital

Brief Summary:

Amputation of a limb may result from trauma or surgical intervention. The amputation traumatically alters the body image, but often leaves sensations that refer to the missing body part. In 50-80% amputees, neuropathic pain develops, also called phantom limb pain (PLP). Both peripheral and central nervous system factors have been implicated as determinants of PLP. Also, PLP may be triggered by physical (changes in the weather) and psychological factors (emotional stress). Recent evidence suggests that PLP may be intricately related to neuroplastic changes in the cortex, and that these changes may modulated by providing sensory input to the stump or amputation zone.

A non-invasive clinical trial will test the effectiveness of non-invasive pressure sensory feedback build into a hand prosthesis to alleviate phantom limb pain.


Condition or disease Intervention/treatment Phase
Phantom Limb Pain Behavioral: Non-invasive sensory feedback Not Applicable

Detailed Description:

During the pre-screen phase the investigators will assess whether the patient experiences referred phantom limb sensations or pain. In the case that the patient does experience referred sensations on the stump the investigators will map the areas where the sensation occurs on the stump and utilize this for placement of the surface actuators. In the opposite case, actuators will instead be placed in a matrix structure at the residual limb.

As a first step towards applying mechanical stimulation, the sensation thresholds (the level of stimulation where the subject first reports a sensation) have to be determined. The outcome of this procedure is a minimum of stimulation amplitude that can be applied for each stimulation site.

A first choice would be to use the referred map to place actuators. However, amputees have different phantom maps and also the number of areas varies.

A therapy will be defined based on the use of sensory feedback system integrated with the amputees hand prosthesis. The subject should use the hand prosthesis, with sensory feedback, for a duration of minimum 2 h per day during a 4 week period.

Preferably, the system should be used actively in normal daily activities.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis
Study Start Date : January 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: Non-invasive sensory feedback Behavioral: Non-invasive sensory feedback
A non-invasive simple sensory feedback system, which provides the user of a prosthetic hand with sensory feedback on the arm stump. It is mediated by air in a closed loop system connecting silicone pads on the prosthetic hand with pads on the amputation stump. The silicone pads in a "tactile display" on the amputation stump expand when their corresponding sensor-bulb in the prosthesis is touched, evoking an experience of "real touch". Most amputees experience phantom limb sensations and/or phantom limb pain, as well as residual limb stump pain. There is often a "map" of the phantom hand on the amputation stump, where pressure on specific skin areas result in evoked sensation from specific fingers in the amputated phantom hand. This map is the target for the sensory feedback.




Primary Outcome Measures :
  1. Change in phantom Limb pain [ Time Frame: Baseline and after 4 week treatment ]
    Baseline status includes: phantom limb pain assessed using visual analogue scale.


Secondary Outcome Measures :
  1. Cortical reorganization [ Time Frame: Baseline and after 4 week treatment (2 hours/day) ]
    MRI: Change in cortical response during sensory stimulation is examined



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

Inclusion Criteria:

  • Transradial amputation
  • Amputation should be in a stable phase
  • Other treatments for PLP tried with poor result
  • PLP experienced as over 6 on a visual analogue scale

Exclusion Criteria:

  • Cognitive impairment
  • Pregnancy
  • History of active substance abuse disorder
  • Acquired brain injury with residual impairment
  • Intelligence disability
  • Neurologic or musculoskeletal disease or other diseases that may affect the function of nervous system
  • Pacemaker
  • dermatologic condition

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): NCT02589080


Locations
Sweden
Fredrik Sebelius
Lund, Sweden, SE-22100
Sponsors and Collaborators
Lund University Hospital
Aalborg Universitetshospital
University of Freiburg
Université Montpellier
Indiana University School of Medicine
Ecole Polytechnique Fédérale de Lausanne
Universitat Autonoma de Barcelona
Catholic University of the Sacred Heart
Aalborg University
Investigators
Principal Investigator: Fredrik Sebelius, PhD Lund University

Responsible Party: Goran Lundborg, Professor Göran Lundborg, Lund University Hospital
ClinicalTrials.gov Identifier: NCT02589080     History of Changes
Other Study ID Numbers: EPIONE-LU
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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