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

NCT02796495 | Withdrawn

• 2 other identifiers: EPIONE-602547-7602547
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Phantom Limb Pain

Keywords

Neuroplasticity; Sensory Feedback; Nerve stimulation; Robotic Hand

Outcome Measures

Primary Outcomes (2)

• Phantom limb pain (questionnaires)

  The pain intensity will be assessed using visual analog scale (VAS)

  Change in phantom limb pain perception during the all study (from baseline to maximum 6 months)

• Cortical reorganization (fMRI)

  The cortical response to peripheral stimulation will be tracked using fMRI

  Change in cortical reorganization before and at the end of treatment (from baseline to maximum 6 months)

Secondary Outcomes (2)

• Phantom limb pain (questionnaires)

  Change in neuropathic pain symptoms during the all study (from baseline to maximum 6 months)

• Cortical reorganization (EEG)

  Change in cortical reorganization before and at the end of treatment (from baseline to maximum 6 months)

Study Arms (1)

Operation of hand prosthesis with direct nerve stimulation

EXPERIMENTAL

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: * 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 * The EPIONE Psychophysical Testing Platform software for stimulator control

Device: Operation of hand prosthesis with direct nerve stimulation

Interventions

Operation of hand prosthesis with direct nerve stimulation DEVICE

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.

Operation of hand prosthesis with direct nerve stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transradial amputation.
• Amputation should be in the chronic, stable phase, such that the stump has healed and the person apart from eventual phantom pain (PLP) is healthy and able to carry out experiments.
• Other treatments for PLP tried with poor results.
• Patient accepts the study protocol as explained by the physician.
• The subject experienced intractable PLP of more than 6 on NRS or VAS (0-10 scale). The frequency of PLP episodes presents more than once a week.

You may not qualify if:

• Cognitive impairment
• Current or prior psychological impairments: Major personality disturbance (i.e. borderline, antisocial), Major depression, Bipolar I.
• Pregnancy
• History of or active substance abuse disorder
• Acquired brain injury with residual impairment
• Intellectual Disability (IQ \< 70)
• Prior neurological or musculoskeletal disease
• Current or prior dermatological conditions
• Excessive sensitivity to electrical stimulation with surface electrodes. People afraid of electrical stimulation or pain.
• People with other diseases which may affect the function of the nervous system. (Diabetes, HIV, Renal Failure)
• Patients implanted with pacemakers

Sponsors & Collaborators

• Prof. Wassim Raffoul: lead
• Aalborg University Hospital: collaborator
• University of Freiburg: collaborator
• Université Montpellier: collaborator
• Lund University: collaborator
• Indiana University School of Medicine: collaborator
• Novosense AB: collaborator
• Mxm-Obelia: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• Universitat Autonoma de Barcelona: collaborator
• Catholic University of the Sacred Heart: collaborator
• Aalborg University: collaborator

Study Sites (1)

University of Lausanne Hospital CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Wassim Raffoul, Professor

  University Hospital Lausanne CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 10, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)