Use of Hand Prosthesis With Surface Electrical Stimulation for Treatment of Phantom Limb Pain

NCT02569918 | Completed

• 2 other identifiers: EPIONE-602547-4602547
• Study Type: interventional
• Target: 2
• 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

Neuroplasticity; Sensory Feedback; Transcutaneous electrical stimulation; Robotic hand

Outcome Measures

Primary Outcomes (2)

• Phantom limb pain

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

  Change in phantom limb pain perception between baseline measurements and 3 months

• Cortical reorganization

  The cortical response to peripheral stimulation will be tracked using MRI

  Change in cortical reorganization between baseline measurements and 3 months

Secondary Outcomes (2)

• Phantom limb pain

  Change in neuropathic pain symptoms between baseline measurements and 3 months

• Cortical reorganization

  Change in in cortical reorganization between baseline measurements and 3 months

Study Arms (1)

Surface electrical stimulation

EXPERIMENTAL

Operation of hand prosthesis with surface electrical sensory feedback

Device: Surface electrical stimulation

Interventions

Surface electrical stimulation DEVICE

Surface electrical stimulation using the following experimental devices. 1) The CE-approved HASOMED electrical isolated stimulator (Rehastim). 2) Two hand prosthesis: the robotic hand "Azzurra" (Prensilia, Italy) and the robotic hand "Multi-sensory Prosthetic Hand" (Wessling robotics, Germany) 3) 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 - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Amputation or peripheral nerve damage of an upper limb.
• Injury should be in the chronic, stable phase, such that any traumatic injuries or surgical wounds have healed and the person apart from eventual phantom pain (PLP) is healthy and able to carry out experiment.
• Other treatments for PLP tried with poor results.
• Patient accepts the study protocol as explained by the physician.
• The subject experienced intractable PLP (i.e. pain in the denervated or missing extremity) of more than 6 on numerical rating scale (NRS) or visual analog scale (VAS) (0-10 scale). The frequency of PLP episodes presents more than once a week.
• Amputee subjects without PLP are eligible for part of the study that targets the sensory feedback induction within advanced bidirectional prosthesis control.

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 of Lausanne Hospitals

  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: October 6, 2015
• First Posted: October 7, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

CH (1)