Phantom Limb Pain Clinical Trial
Official title:
Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain
The goal of the clinical investigation is to reduce phantom limb pain (PLP), painful condition affecting 70% of amputees, so as to improve these patients' quality of life.
The goal of the clinical investigation is to reduce phantom limb pain (PLP), a painful
condition affecting 70% of amputees, so as to improve these patients' quality of life.
Traditionally, mirror box therapy and other tools based on the same concept, have been used
to alleviate pain, but their efficacy varies greatly. This project targets amputees for whom
other PLP treatments have failed. Various virtual environments, including virtual/augmented
reality, are controlled by the patient's phantom limb using muscle (myoelectric) signals
from the stump. The patient learns to reactivates areas in the brain related to motor
control of the missing limb.
The medical device is non-invasive and based on surface electromyography, a standard and
widely used clinical and research tool. The surface electrodes are a standard disposable
electrodes widely used in clinics and hospitals for EMG and/or ECG.
- Myoelectric amplifiers (battery operated and isolated from the power grid)
- Data acquisition electronics
- Personal computer
- Standard webcam
- Myoelectric pattern recognition (MPR) software
- Virtual Reality (VR)
- Augmented Reality (AR)
- Computer game
The clinical investigation period consists of 12 sessions per patient including 3 short
follow-up assessments. Length of the session: 1.5 hours (the first sessions can take longer
time due to learning/familiarization). The centers participating in this study can choose
between the following treatment administrations:
- 2 times per week (advised)
- 1 time per week
- Daily (5 times per week)
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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