Use of Hand Prosthesis With Direct Nerve Stimulation for Treatment of Phantom Limb Pain (EPIONE)
Phantom Limb Pain
About this trial
This is an interventional treatment trial for Phantom Limb Pain focused on measuring Neuroplasticty, Sensory Feedback
Eligibility Criteria
Inclusion Criteria:
- Uni-lateral amputation below the shoulder level
- Other treatments for phantom limb pain should have been tried with poor results
- The subject should experience phantom limb pain at a level of 6 or higher measured on on a visual analog scale (VAS) ranging from 0-10
- Phantom limb pain should be experienced at leaste once a week
- The subject should be in a chronica and stable phase, and the stump should have healed
- The subject should otherwise be healthy and able to carry out the experiment
- If pain medication is used it will be acceptable that the person continues to use the medication
Exclusion Criteria:
- Cognitive impairment
- Pregnancy
- Prior or current psychological diseases such as borderline, schizophrenia, depression or maniodepression
- Acquired brain injury with residual impairment
- Prior neurological or muscoloskeletal diseases
- History of or active substance abuse disorder
- Excessive sensitivity to electrical stimulation with surface electrodes
- Persons with fear for electrical stimulation, pain cannot participate
- Persons that are hypersensitive to electrical stimulation and experience the stimulation as unpleasent cannot participate
- Since the protocol includes MRI scanning of the brain, persons that may feel claustrophobic cannot participate
- Since the protocol includes MRI scanning of the brain, persons that have metal parts in the body (such as pacemakers or bone-screws) cannot participate
Sites / Locations
- Paolo Maria Rossini
Arms of the Study
Arm 1
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: STIMEP (multichannel electrical stimulator for the peripheral nervous system; AXONIC) TIME 4H Intraneural Electrodes (ALBERT-LUDWIGS-UNIVERSITAET FREIBURG) Sensorized hand Prosthetics for amputees IH2 Prosthetic Azurra Prensilia (Prensilia Ltd.) Prosthetics sensorized hand for amputees DLR / HIT Hand II (Wessling Robotics) ODROID software integration within the afferent and efferent bi-directional control of the robotic hand