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

Primary Purpose

Phantom Limb Pain

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Non-invasive sensory feedback
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fredrik Sebelius

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-invasive sensory feedback

Arm Description

Outcomes

Primary Outcome Measures

Change in phantom Limb pain
Baseline status includes: phantom limb pain assessed using visual analogue scale.

Secondary Outcome Measures

Cortical reorganization
MRI: Change in cortical response during sensory stimulation is examined

Full Information

First Posted
October 11, 2015
Last Updated
August 15, 2018
Sponsor
Lund University Hospital
Collaborators
Aalborg University Hospital, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02589080
Brief Title
Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis
Acronym
EPIONE
Official Title
Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University Hospital
Collaborators
Aalborg University Hospital, 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-invasive sensory feedback
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Non-invasive sensory feedback
Intervention Description
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 Measure Information:
Title
Change in phantom Limb pain
Description
Baseline status includes: phantom limb pain assessed using visual analogue scale.
Time Frame
Baseline and after 4 week treatment
Secondary Outcome Measure Information:
Title
Cortical reorganization
Description
MRI: Change in cortical response during sensory stimulation is examined
Time Frame
Baseline and after 4 week treatment (2 hours/day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Sebelius, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fredrik Sebelius
City
Lund
ZIP/Postal Code
SE-22100
Country
Sweden

12. IPD Sharing Statement

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

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