Use of Hand Prosthesis With Direct Nerve Stimulation for Treatment of Phantom Limb Pain (EPIONE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02796495|
Recruitment Status : Withdrawn (Study has been completed in terms of duration but no patient has been recruited during this time)
First Posted : June 10, 2016
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Phantom Limb Pain||Device: Operation of hand prosthesis with direct nerve stimulation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Natural Sensory Feedback for Phantom Limb Modulation and Therapy|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Experimental: Operation of hand prosthesis with direct nerve stimulation
A system composed by the integration of the following non-CE marked medical devices specifically designed for the study will be used in one or two amputees:
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.
- Phantom limb pain (questionnaires) [ Time Frame: Change in phantom limb pain perception during the all study (from baseline to maximum 6 months) ]The pain intensity will be assessed using visual analog scale (VAS)
- Cortical reorganization (fMRI) [ Time Frame: Change in cortical reorganization before and at the end of treatment (from baseline to maximum 6 months) ]The cortical response to peripheral stimulation will be tracked using fMRI
- Phantom limb pain (questionnaires) [ Time Frame: Change in neuropathic pain symptoms during the all study (from baseline to maximum 6 months) ]The pain symptoms will be assessed using the Neuropathic Pain Symptom Inventory (NPSI)
- Cortical reorganization (EEG) [ Time Frame: Change in cortical reorganization before and at the end of treatment (from baseline to maximum 6 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): NCT02796495
|University of Lausanne Hospital CHUV|
|Lausanne, Vaud, Switzerland, 1011|
|Principal Investigator:||Wassim Raffoul, Professor||University Hospital Lausanne CHUV|