Use of Hand Prosthesis With Surface Electrical Stimulation for Treatment of Phantom Limb Pain
NCT02569918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2017-11-14
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 experimental devices. 1) The CE-approved HASOMED electrical isolated stimulator (Rehastim). 2) Two hand prosthesis: the robotic hand "Azzurra" (Prensilia, Italy) and the robotic hand "Multi-sensory Prosthetic Hand" (Wessling robotics, Germany) 3) 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 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
collaborator OTHER -
Prof. Wassim Raffoul
lead OTHER
Principal Investigators
-
Wassim Raffoul, Professor · University of Lausanne Hospitals
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
- 2015-02-28
- Primary Completion
- 2017-11-30
- Completion
- 2017-11-30
Countries
- Switzerland
Study Locations
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