Use of Hand Prosthesis With Direct Nerve Stimulation for Treatment of Phantom Limb Pain

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 invasive sensory feedback (i.e. electrical stimulation through intraneural implantation of electrodes) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.

Conditions

• Phantom Limb Pain

Interventions

DEVICE

Operation of hand prosthesis with direct nerve stimulation

Four TIME-4H electrodes will be implanted in the median and ulnar nerves of the amputees. The electrodes will be connected with the STIMEP electrical multichannel stimulator. The stimulator will be connected with one of the two sensorized hand prosthesis. Afferent and efferent signals will be elaborated and integrated by the ODROID software. The amputees will be able to control the prosthetic hand movement and receive a sensory feedback from the prosthesis sensors. The use of the prosthesis during different tasks will be considered the intervention.

Sponsors & Collaborators

• University of Freiburg

  collaborator OTHER

• Université Montpellier

  collaborator OTHER

• Lund University

  collaborator OTHER

• Aalborg University Hospital

  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

  collaborator OTHER

• Prof. Wassim Raffoul

  lead OTHER

Principal Investigators

• Wassim Raffoul, Professor · University Hospital Lausanne CHUV

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

2016-05-31

Primary Completion

2017-11-30

Completion

2017-11-30

Countries

• Switzerland

Study Locations