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

Phantom Limb Pain Clinical Trial

— EPIONE  

Official title:

Natural Sensory Feedback for Phantom Limb Modulation and Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506608
• Other study ID #: EPIONE-602547-6
• Secondary ID: no. 602547
• Status: Completed
• Phase: N/A
• First received: July 20, 2015
• Last updated: December 4, 2017
• Start date: June 2015
• Est. completion date: September 2017

Study information

• Verified date: December 2017
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 sensory feedback (i.e. surface or neural electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain

Intervention

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.

Locations

Country	Name	City	State
Italy	Paolo Maria Rossini	Roma	IT

Sponsors (12)

Lead Sponsor	Collaborator
Paolo Maria Rossini	Aalborg Universitetshospital, Aalborg University, Ecole Polytechnique Fédérale de Lausanne, Indiana University School of Medicine, Lund University, Mxm-Obelia, Novosense AB, Universitat Autonoma de Barcelona, Université Montpellier, University of Freiburg, University of Lausanne Hospitals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phantom limb pain	Questionnaires (Visual Analogic Scale, Neuropathic Pain Symptom Inventory )	Change in Phantom Limb Pain daily during the whole study (maximum 1 year per patient)
Primary	Cortical reorganization	Electroencephalography; Transcranial Magnetic Stimulation and electroencephalography; functional Magnetic Resonance Imaging; Transcranial Magnetic Stimulation ; Somatosensory Evoked Potentials	Change in Cortical reorganization before and at the end of 1 year of treatment