Phantom Motor Execution Via MPR, VR/AR, and SG, as a Treatment of PLP

Summary

This international, multi-center, double-blind, randomized, controlled clinical trial aims to evaluate the efficacy of Phantom Motor Execution (PME) and Phantom Motor Imagery (PMI) as treatments of Phantom Limb Pain (PLP). In PME, myoelectric pattern recognition (MPR) is used to predict motor volition and then use the decoded movements to control virtual and augmented reality environments (VR/AR), along with serious gaming (SG). The same device and VR/AR environments are used in PMI with the difference that subjects will imagine rather than execute phantom movements. Electromyography is used to monitor for no muscular activity in PMI.

Conditions

• Phantom Limb Pain

Interventions

DEVICE

Phantom Motor Execution

Neuromotus - PME decodes motor volition applying machine learning to surface electromyography. Once the intention of movement is known, this is use to control serious games in virtual and augmented reality. A treatment session of MPE consists of: 1. Pain evaluation 2. Placement of the electrodes and fiducial marker 3. Practice of motor execution in Augmented Reality (AR) 4. Gaming using phantom movements 5. Practice of motor execution by matching random target postures of a virtual limb. Step 3 to 4 are repeated for different phantom joints, initially one at the time progressing to several joints simultaneously. A treatment session last 2 hours.

DEVICE

Phantom Motor Imagery

The only difference between PME and PMI is that in the former myoelectric signals are used to give the participants control over the virtual environments, whereas in PMI the presence of myoelectric activity is used as an alarm to remind the participant that it must imagine rather than execute the phantom movement. In PMI the virtual environments act autonomously to guide the participant in imagination of movement.

Sponsors & Collaborators

• Chalmers University of Technology

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Örebro University, Sweden

  collaborator OTHER

• Bräcke Diakoni, Sweden

  collaborator UNKNOWN

• University Rehabilitation Institute, Republic of Slovenia

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• University of New Brunswick

  collaborator OTHER

• National University of Ireland, Galway, Ireland

  collaborator OTHER

• Shirley Ryan AbilityLab

  collaborator OTHER

• Ruhr University of Bochum

  collaborator OTHER

• Integrum

  lead INDUSTRY

Principal Investigators

• Max Ortiz Catalan, PhD · Chalmers Technological University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-08

Primary Completion

2021-03-12

Completion

2021-09-20

Countries

• United States
• Canada
• Germany
• Ireland
• Netherlands
• Slovenia
• Sweden

Study Locations