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

Phantom Limb Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281539
• Other study ID #: PLP-004664
• Status: Completed
• Phase: N/A
• First received: October 12, 2014
• Last updated: May 25, 2016
• Start date: September 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: Integrum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Amputee patients older than 18 years.

• The patient has signed a written informed consent.

• Patients must have been treated with at least one of the following therapies:

1. Conventional mirror training

2. Transcutaneous electrical stimulation (TENS)

3. Acupuncture

4. Self-hypnosis

5. Drug-based

• The last session of previous therapies (1 and 2) must be at least 1 month before beginning the treatment here proposed.

• In the case of drug-based treatments (5), the patient must report no PLP reduction for at least 1 month under the drug-based treatment and no variations on the medicaments dose. Any pain reduction potentially attributed to the drug-based treatment must be at least 3 months old.

• At least a portion of biceps and triceps muscles must be present.

Exclusion Criteria:

• Patient must not have a significant cognitive impairment that prevents them from following instructions.

• Upper limb amputees excluding shoulder disarticulation.

• Obese patient will not be automatically excluded, however, an evaluation in the system is required to analyse if sufficient electromyography signals can be recorded.

• Stump pain over 2 VAS of pain.

• Participating in any other clinical study that could interfere with the result in the ongoing study.

• Condition associated with risk of poor protocol compliance.

• Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgement.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain

Intervention

Device:
• Neuromotus

Locations

Country	Name	City	State
Sweden	Rehabilitation Center for Upper Limb Prosthetics	Gothenburg

Sponsors (5)

Lead Sponsor	Collaborator
Integrum	Bräcke diakoni Rehabcenter Sfären, Sahlgrenska University Hospital, Sweden, University Hospital Orebro, University Rehabilitation Institute Republic of Slovenia

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Ortiz-Catalan M, Sander N, Kristoffersen MB, Håkansson B, Brånemark R. Treatment of phantom limb pain (PLP) based on augmented reality and gaming controlled by myoelectric pattern recognition: a case study of a chronic PLP patient. Front Neurosci. 2014 Fe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the portion of patients that had a reduction of PLP according to the calculated weighted pain distribution (WPD)	Each patient is asked to estimate the time spent in a given level of pain (as by VAS). The WPD is the sum of the portion of time multiplied with the pain level (0 to 5). This can also be explained as weighted mean calculation. The time with a given level of pain can be estimated in minutes/hours and extrapolated to its corresponding portion from the total time. Phantom Limb pain, which is a chronic pain, is difficult to describe can not be assesst in a single point in time. That is why patients are asked to fill in the amount of time they spend in each level of pain.	12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.	No
Secondary	Descriptive analysis on the effect of the proposed treatment on quality of life, disability at the activity and participation levels.(DASH/COPM/EQ-5D)	Questionnaires are answered before the first treatment and after the last treatment. Patients will also answer the questionnaires for a follow-up.	12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.	No
Secondary	Measure the portion of patients that had a reduction of PLP with the use of visual analog scale and reduction on the "pain rating index".	For the Pain Rating Index (PRI), each selected word is scored from 0 (none) to 5 (Excruciating pain). The total Pain Rating Index score is obtained by summing the item scores and higher score indicates worse pain.	12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.	No
Secondary	Descriptive analysis on the effect of the proposed treatment in medicaments intake	questionnaires compared	12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.	No
Secondary	Patients having the same treatment administration will be classified in subgroups and their results compared.	questionnaires compared	12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.	No