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

Primary Purpose

Phantom Limb Pain

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Neuromotus

About this trial

This is an interventional treatment trial for Phantom Limb Pain focused on measuring Phantom Limb Pain, Augmented Reality, Myoelectric control, Virtual reality, electromyography, pattern recognition, neurorehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rehabilitation Center for Upper Limb Prosthetics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment using myoelectric signals

Arm Description

Virtual- and augmented reality, are controlled by the patient's phantom limb using muscle (myoelectric) signals from the stump. The patient learns to reactivate areas in the brain related to motor control of the missing limb. The medical device is non-invasive and based on surface electromyography

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Descriptive analysis on the effect of the proposed treatment in medicaments intake

questionnaires compared

Patients having the same treatment administration will be classified in subgroups and their results compared.

questionnaires compared

Full Information

NCT ID

NCT02281539

First Posted

October 12, 2014

Last Updated

May 25, 2016

Sponsor

Integrum

Collaborators

Sahlgrenska University Hospital, Sweden, Region Örebro County, Bräcke diakoni Rehabcenter Sfären, University Rehabilitation Institute, Republic of Slovenia

1. Study Identification

Unique Protocol Identification Number

NCT02281539

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Integrum

Collaborators

Sahlgrenska University Hospital, Sweden, Region Örebro County, Bräcke diakoni Rehabcenter Sfären, University Rehabilitation Institute, Republic of Slovenia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Phantom Limb Pain

Keywords

Phantom Limb Pain, Augmented Reality, Myoelectric control, Virtual reality, electromyography, pattern recognition, neurorehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment using myoelectric signals

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Neuromotus

Primary Outcome Measure Information:

Title

Measuring the portion of patients that had a reduction of PLP according to the calculated weighted pain distribution (WPD)

Description

Time Frame

12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

Secondary Outcome Measure Information:

Title

Descriptive analysis on the effect of the proposed treatment on quality of life, disability at the activity and participation levels.(DASH/COPM/EQ-5D)

Description

Questionnaires are answered before the first treatment and after the last treatment. Patients will also answer the questionnaires for a follow-up.

Time Frame

12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

Title

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".

Description

Time Frame

12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

Title

Descriptive analysis on the effect of the proposed treatment in medicaments intake

Description

questionnaires compared

Time Frame

12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

Title

Patients having the same treatment administration will be classified in subgroups and their results compared.

Description

questionnaires compared

Time Frame

12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Conventional mirror training Transcutaneous electrical stimulation (TENS) Acupuncture Self-hypnosis 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rickard Brånemark, MD MSC, PhD

Organizational Affiliation

Integrum AB

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Kerstin Caine-Winterberger, OT

Organizational Affiliation

Rehabilitation Center for Upper Limb Prosthetics, Sahlgrenska University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rehabilitation Center for Upper Limb Prosthetics

City

Gothenburg

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

24616655

Citation

Ortiz-Catalan M, Sander N, Kristoffersen MB, Hakansson B, Branemark 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 Feb 25;8:24. doi: 10.3389/fnins.2014.00024. eCollection 2014.

Results Reference

result

PubMed Identifier

27916234

Citation

Ortiz-Catalan M, Guethmundsdottir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragno C, Pihlar Z, Burger H, Hermansson L. Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain. Lancet. 2016 Dec 10;388(10062):2885-2894. doi: 10.1016/S0140-6736(16)31598-7. Epub 2016 Dec 2.

Results Reference

derived

Learn more about this trial

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

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