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: NCT02506608|
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment|
|Phantom Limb Pain||Procedure: Operation of sensorized hand prosthesis|
|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 :||June 2015|
|Primary Completion Date :||September 2017|
|Study Completion Date :||September 2017|
Experimental: Operation of sensorized hand prosthesis
A system composed by the integration of the following non-CE marked medical devices specifically designed for the study will be used in amputees:
Procedure: Operation of sensorized hand prosthesis
Four TIME-4H electrodes will be implanted in the median and ulnar of the amputees. The electrodes will be connected with the STIMEP electrical multichannel stimulator. The stimulator will be connected with one of the sensorized prostheses. Afferent and efferent signals will be elaborated and integrated by the ODROID software.
The amputees will be able to control the prostheses 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 [ Time Frame: Change in Phantom Limb Pain daily during the whole study (maximum 1 year per patient) ]Questionnaires (Visual Analogic Scale, Neuropathic Pain Symptom Inventory )
- Cortical reorganization [ Time Frame: Change in Cortical reorganization before and at the end of 1 year of treatment ]Electroencephalography; Transcranial Magnetic Stimulation and electroencephalography; functional Magnetic Resonance Imaging; Transcranial Magnetic Stimulation ; Somatosensory Evoked Potentials
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): NCT02506608
|Paolo Maria Rossini|
|Roma, IT, Italy, 00168|