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

NCT02589080 | Completed

• 1 other identifier: EPIONE-LU
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phantom Limb Pain

Outcome Measures

Primary Outcomes (1)

• Change in phantom Limb pain

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

  Baseline and after 4 week treatment

Secondary Outcomes (1)

• Cortical reorganization

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

Study Arms (1)

Non-invasive sensory feedback

EXPERIMENTAL

Behavioral: Non-invasive sensory feedback

Interventions

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.

Non-invasive sensory feedback

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University Hospital: lead
• Aalborg University Hospital: collaborator
• University of Freiburg: collaborator
• Université Montpellier: collaborator
• Indiana University School of Medicine: 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)

Fredrik Sebelius

Lund, SE-22100, Sweden

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

• Fredrik Sebelius, PhD

  Lund 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: PRINCIPAL INVESTIGATOR
• PI Title: Professor Göran Lundborg

Study Record Dates

• First Submitted: October 11, 2015
• First Posted: October 28, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

SE (1)