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Completed

NCT Number: NCT02589080

Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis

Amputation of a limb may result from trauma or surgical intervention. The amputation traumatically alters the body image, but often leaves sensations that refer to the missing body part. In 50-80% amputees, neuropathic pain develops, also called phantom limb pain (PLP). Both peripheral and central nervous system factors have been implicated as determinants of PLP. Also, PLP may be triggered by physical (changes in the weather) and psychological factors (emotional stress). Recent evidence suggests that PLP may be intricately related to neuroplastic changes in the cortex, and that these changes may modulated by providing sensory input to the stump or amputation zone.

A non-invasive clinical trial will test the effectiveness of non-invasive pressure sensory feedback build into a hand prosthesis to alleviate phantom limb pain.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fredrik Sebelius

Lund, SE-22100, Sweden

About this study

During the pre-screen phase the investigators will assess whether the patient experiences referred phantom limb sensations or pain. In the case that the patient does experience referred sensations on the stump the investigators will map the areas where the sensation occurs on the stump and utilize this for placement of the surface actuators. In the opposite case, actuators will instead be placed in a matrix structure at the residual limb.

As a first step towards applying mechanical stimulation, the sensation thresholds (the level of stimulation where the subject first reports a sensation) have to be determined. The outcome of this procedure is a minimum of stimulation amplitude that can be applied for each stimulation site.

A first choice would be to use the referred map to place actuators. However, amputees have different phantom maps and also the number of areas varies.

A therapy will be defined based on the use of sensory feedback system integrated with the amputees hand prosthesis. The subject should use the hand prosthesis, with sensory feedback, for a duration of minimum 2 h per day during a 4 week period.

Preferably, the system should be used actively in normal daily activities.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Transradial amputation
  • Amputation should be in a stable phase
  • Other treatments for PLP tried with poor result
  • PLP experienced as over 6 on a visual analogue scale

Exclusion criteria

  • Cognitive impairment
  • Pregnancy
  • History of active substance abuse disorder
  • Acquired brain injury with residual impairment
  • Intelligence disability
  • Neurologic or musculoskeletal disease or other diseases that may affect the function of nervous system
  • Pacemaker
  • dermatologic condition

Treatment and study plan

Non-invasive sensory feedback

Behavioral

A non-invasive simple sensory feedback system, which provides the user of a prosthetic hand with sensory feedback on the arm stump. It is mediated by air in a closed loop system connecting silicone pads on the prosthetic hand with pads on the amputation stump. The silicone pads in a "tactile display" on the amputation stump expand when their corresponding sensor-bulb in the prosthesis is touched, evoking an experience of "real touch". Most amputees experience phantom limb sensations and/or phantom limb pain, as well as residual limb stump pain. There is often a "map" of the phantom hand on the amputation stump, where pressure on specific skin areas result in evoked sensation from specific fingers in the amputated phantom hand. This map is the target for the sensory feedback.

Primary outcomes

  1. Change in phantom Limb pain

    Time frame: Baseline and after 4 week treatment

    Baseline status includes: phantom limb pain assessed using visual analogue scale.

Secondary outcomes

  1. Cortical reorganization

    Time frame: Baseline and after 4 week treatment (2 hours/day)

    MRI: Change in cortical response during sensory stimulation is examined

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Collaborators

  • Aalborg University
  • Aalborg University Hospital
  • Catholic University of the Sacred Heart
  • Ecole Polytechnique Fédérale de Lausanne
  • Indiana University
  • Universitat Autonoma de Barcelona
  • University of Freiburg
  • Université Montpellier

Registry information

Acronym: EPIONE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2015
Registry last updated
Aug 17, 2018

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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