This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Use of Hand Prosthesis With Direct Nerve Stimulation for Treatment of Phantom Limb Pain (EPIONE)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2015 by Paolo Maria Rossini, Catholic University of the Sacred Heart
Sponsor:
Information provided by (Responsible Party):
Paolo Maria Rossini, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT02506608
First received: July 20, 2015
Last updated: July 22, 2015
Last verified: July 2015
  Purpose
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 Intervention
Phantom Limb Pain Procedure: Operation of sensorized hand prosthesis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Natural Sensory Feedback for Phantom Limb Modulation and Therapy

Resource links provided by NLM:


Further study details as provided by Paolo Maria Rossini, Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 2
Study Start Date: June 2015
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 two 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
Procedure: Operation of sensorized hand prosthesis

Four TIME-4H electrodes will be implanted in the median and ulnar nerves of he 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.


  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uni-lateral amputation below the shoulder level
  • Other treatments for phantom limbe 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 feel may 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02506608

Contacts
Contact: Paolo Maria Rossini, Full professor 00390635504435 paolomaria.rossini@afar.it

Locations
Italy
Paolo Maria Rossini Recruiting
Roma, IT, Italy, 00168
Contact: Paolo Maria Rossini, Professor    00390635504435    paolomaria.rossini@afar.it   
Sponsors and Collaborators
Paolo Maria Rossini
  More Information

Responsible Party: Paolo Maria Rossini, MD, PhD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02506608     History of Changes
Other Study ID Numbers: EPIONE-602547-6
no. 602547 ( Other Grant/Funding Number: no. 602547 )
Study First Received: July 20, 2015
Last Updated: July 22, 2015

Keywords provided by Paolo Maria Rossini, Catholic University of the Sacred Heart:
Neuroplasticty, Sensory Feedback

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on June 22, 2017