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Completed

NCT Number: NCT02506608

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paolo Maria Rossini

Roma, IT, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Operation of sensorized hand prosthesis

Procedure

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.

Primary outcomes

  1. 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 )

  2. 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

Sponsors and collaborators

Lead sponsor

Paolo Maria Rossini

Other

Collaborators

  • Aalborg University
  • Aalborg University Hospital
  • Ecole Polytechnique Fédérale de Lausanne
  • Indiana University
  • Lund University
  • Mxm-Obelia
  • Novosense AB
  • Universitat Autonoma de Barcelona
  • University of Freiburg
  • University of Lausanne Hospitals
  • Université Montpellier

Registry information

Official study title

Natural Sensory Feedback for Phantom Limb Modulation and Therapy

Acronym: EPIONE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 23, 2015
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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