Surface Electrical Stimulation for Treatment of Phantom Limb Pain

NCT02488668 | Completed

• 2 other identifiers: EPIONE-602547-1602547
• Study Type: interventional
• Target: 20
• 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 non-invasive sensory feedback (i.e. surface electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.

Conditions

Phantom Limb Pain

Keywords

Transcutaneous Electrical Stimulation; Neuroplasticity; Sensory Feedback

Outcome Measures

Primary Outcomes (2)

• Phantom limb pain

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

  Change in pain perception over three months

• Cortical reorganization

  The cortical response to peripheral stimulation will be tracked using MRI

  Change in cortical reorganization over three months

Secondary Outcomes (2)

• Cortical reorganization

  Change in cortical reorganization over three months

• Phantom limb pain

  Change in neuropathic pain symptoms over three months

Study Arms (1)

Surface Electrical Stimulation

EXPERIMENTAL

Please see information under 'Detailed description'

Device: Surface Electrical Stimulation

Interventions

Surface Electrical Stimulation DEVICE

Surface electrical stimulation using the following devices; 1) INOMED surface stimulator, 2) The EPIONE Psychophysical Testing Platform software for stimulator control. Surface stimulation therapy is provided while providing visual guidance to the subject.

Surface Electrical Stimulation

Eligibility Criteria

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

You may qualify if:

• Amputation of one or both arms below the shoulder level or amputation of one or both legs below hip joint
• Total or partial peripheral nerve injury (i.e.,under spinal cord level) causing paralysis of the arms or legs
• 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 least once a week
• The subject should be in a chronic 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
• It should, through peripheral electrical stimulation, be possible to apply the relevant phantom emotions to the subject

You may not qualify if:

• Cognitive impairment
• Pregnancy
• Prior or current psychological diseases such as borderline, schizophrenia, depression or manic-depressive
• Acquired brain injury with residual impairment
• Prior neurological or musculoskeletal diseases
• History of or active substance abuse disorder
• Persons with that experience an allergic reaction to surface electrodes
• Persons with fear for electrical stimulation or pain
• Persons that are hypersensitive to electrical stimulation and experience the stimulation as unpleasant
• Persons that feel may claustrophobic in an MRI scanner
• Persons that have metal parts in the body (such as pacemakers or metal screws)

Sponsors & Collaborators

• Winnie Jensen: lead
• Aalborg University Hospital: collaborator
• University of Lausanne Hospitals: 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

Study Sites (1)

Winnie Jensen

Aalborg, Denmark

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

• Winnie Jensen, Ph.D

  Aalborg University

  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: June 30, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

DK (1)