NCT02281539

Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Integrum · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Phantom Limb Pain

Interventions

Type	Name	Description
DEVICE	Neuromotus

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-09-01
• Completion: 2016-01-01
• First posted: 2014-11-03
• Last updated: 2016-05-27

Locations

1 site across 1 country: Sweden