Direct Nerve Stimulation for Treatment of Phantom Limb Pain

Summary

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.

Conditions

• Phantom Limb Pain

Interventions

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.

Sponsors & Collaborators

• Aalborg University

  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

• Aalborg University Hospital

  lead OTHER

Principal Investigators

• Preben Sørensen, MD · Aalborg University Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2017-09-30

Completion

2017-09-30

Countries

• Denmark

Study Locations