Surface Electrical Stimulation for Treatment of Phantom Limb Pain

NCT02488668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-11-14

No results posted yet for this study

Summary

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.

Conditions

  • Phantom Limb Pain

Interventions

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.

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER
  • University of Lausanne Hospitals

    collaborator OTHER
  • University of Freiburg

    collaborator OTHER
  • Université Montpellier

    collaborator OTHER
  • Lund University

    collaborator OTHER
  • Indiana University School of Medicine

    collaborator OTHER
  • Novosense AB

    collaborator INDUSTRY
  • Mxm-Obelia

    collaborator INDUSTRY
  • Ecole Polytechnique Fédérale de Lausanne

    collaborator OTHER
  • Universitat Autonoma de Barcelona

    collaborator OTHER
  • Catholic University of the Sacred Heart

    collaborator OTHER
  • Winnie Jensen

    lead OTHER

Principal Investigators

  • Winnie Jensen, Ph.D · Aalborg University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-09-01
Completion
2017-09-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02488668 on ClinicalTrials.gov