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

Integrum

Status: Completed

Conditions: Phantom Limb Pain

Treatments: Device: Phantom Motor Imagery; Device: Phantom Motor Execution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03112928

007733

Details and patient eligibility

About

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.

Full description

Sixty-six subjects with upper or lower limb amputations are planned to take part in this study. Subjects will be assigned randomly to PME and PMI treatments (2:1 proportion). After treatment completion (15 sessions of 2 hours each) and follow-up period of six months, patients that received PMI will be given the choice to receive PME. The design is double blinded as the patient will be informed that the treatment received, regardless of which, has been shown effective in previous studies. The person conducting the pain evaluations will be blinded to which treatment each patient receives, and will not take part on providing treatment (evaluator and therapist are different persons).

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Subject must be older than 18 years.
• If the subjects are under pharmacological treatments, there must be no variations on the medicament dosages for at least one month (steady consumption).
• The last session of previous treatments must be at least 3 months old.
• Any pain reduction potentially attributed to previous phantom limb pain treatments must be at least 3 months old.
• Subjects must have control over at least a portion of biceps and triceps muscles for upper limb amputations, and quadriceps and hamstrings for the lower limb amputations.
• The subject has signed a written informed consent.
• The subject must be in a stable prosthetic situation (i.e. satisfied with the fitting of the prosthesis) or being a non user.
• At least six months should be passed since the amputation: acute phantom limb pain cases should not be included in the study.
• The patient subject should not have a significant cognitive impairment that prevents the patient from following instructions.
• Subjects with abundant soft tissue on their stump will not be automatically excluded, however, an evaluation in the system is required to analyze if sufficient electromyography signals can be recorded.
• Subjects for whom skin contact or muscle contraction are painful (NRS > 2) are not eligible for the study.
• The subject should not have any condition associated with risk of poor protocol compliance.
• The subject should not have any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgement.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 2 patient groups

Phantom Motor Execution (PME)

Experimental group

Description:

Phantom motor execution is decoded via myoelectric pattern recognition and promoted via serious gaming in virtual and augmented reality.

Treatment:

Device: Phantom Motor Execution

Phantom Motor Imagery (PMI)

Active Comparator group

Description:

Use the same device and visual stimulation as PME, with the difference that participants imagine to perform, rather than execute phantom movements. Myoelectric activity is used to monitor that the subjects do not produce muscular contractions but only imagine the movements.

Treatment:

Device: Phantom Motor Imagery