Use of Hand Prosthesis With Surface Electrical Stimulation for Treatment of Phantom Limb Pain (EPIONE)
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|ClinicalTrials.gov Identifier: NCT02569918|
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : November 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Phantom Limb Pain||Device: Surface electrical stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Natural Sensory Feedback for Phantom Limb Modulation and Therapy|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Experimental: Surface electrical stimulation
Operation of hand prosthesis with surface electrical sensory feedback
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.
- Phantom limb pain [ Time Frame: Change in phantom limb pain perception between baseline measurements and 3 months ]The pain intensity will be assessed using visual analog scale (VAS)
- Cortical reorganization [ Time Frame: Change in cortical reorganization between baseline measurements and 3 months ]The cortical response to peripheral stimulation will be tracked using MRI
- Phantom limb pain [ Time Frame: Change in neuropathic pain symptoms between baseline measurements and 3 months ]The pain symptoms wil be assessed using the neuropathic pain symptom inventory (NPSI)
- Cortical reorganization [ Time Frame: Change in in cortical reorganization between baseline measurements and 3 months ]The cortical response to peripheral stimulation will be tracked using EEG
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569918
|University of Lausanne Hospital CHUV|
|Lausanne, Vaud, Switzerland, 1011|
|Principal Investigator:||Wassim Raffoul, Professor||University of Lausanne Hospitals|