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

Primary Purpose

Phantom Limb Pain

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Phantom Motor Execution

Phantom Motor Imagery

About this trial

This is an interventional treatment trial for Phantom Limb Pain

Eligibility Criteria

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

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.

Sites / Locations

Shirley Ryan Ability Lab
Institue of Biomedical Engineering, University of New Brunswick
Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr - University Bochum (RUB)
School of Psychology, National University of Ireland
University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine
University Rehabilitation Institute
Ortopedteknik, Region Örebro län
Bräcke Diakoni
Gåskolan, Ortopedtekniska avdelningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phantom Motor Execution (PME)

Phantom Motor Imagery (PMI)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Pain Rating Index registered at the beginning (1st session) and at the end of the treatment (15th session).

The Pain Rating Index (PRI) is calculated as the sum of 15 descriptors. At the end of each treatment session the descriptors are presented to the patient, who rates each of them with an intensity scale from 0 to 3. The PRI is therefore a number between 0 and 45: the higher the index the greater is the pain. The primary efficacy variable for this study is the change in PRI between the first and the last treatment session.

Secondary Outcome Measures

Pain Disability Index registered at the beginning (1st session) and the end of the treatment (15th session).

The Pain Disability Index (PDI) measures the impact that pain has on the ability of a person to participate in essential life activities. The index is comprised between 0 and 70. The higher the index the greater the person's disability due to pain is. The secondary efficacy variable of this study is the change in PDI between the first and the last treatment session.

Full Information

NCT ID

NCT03112928

First Posted

April 10, 2017

Last Updated

June 17, 2023

Sponsor

Integrum

Collaborators

Chalmers University of Technology, Sahlgrenska University Hospital, Sweden, Örebro University, Sweden, Bräcke Diakoni, Sweden, University Rehabilitation Institute, Republic of Slovenia, University Medical Center Groningen, University of New Brunswick, National University of Ireland, Galway, Ireland, Shirley Ryan AbilityLab, Ruhr University of Bochum

1. Study Identification

Unique Protocol Identification Number

NCT03112928

Brief Title

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

Official Title

Phantom Motor Execution Via Myoelectric Pattern Recognition, Virtual and Augmented Reality, and Serious Gaming as a Treatment of Phantom Limb Pain

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

May 8, 2017 (Actual)

Primary Completion Date

March 12, 2021 (Actual)

Study Completion Date

September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Integrum

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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).

6. Conditions and Keywords

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

Phantom Limb Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

International, multi-centre, double-blind, randomized, controlled clinical trial

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Participants will be informed that both treatments have been shown effective in previous studies, and in the present study we are comparing their efficacy. The person conducting the pain evaluation (outcomes assessor) will not treat the participants and will be unaware of which treatment is given to each participant. The person treating the subject is different than the person evaluating. The principal and coordinating investigator will receive blinded data from all participating centers to analyze the clinical trial outcomes.

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phantom Motor Execution (PME)

Arm Type

Experimental

Arm Description

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

Arm Title

Phantom Motor Imagery (PMI)

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Phantom Motor Execution

Other Intervention Name(s)

Neuromotus - PME

Intervention Description

Neuromotus - PME decodes motor volition applying machine learning to surface electromyography. Once the intention of movement is known, this is use to control serious games in virtual and augmented reality. A treatment session of MPE consists of: Pain evaluation Placement of the electrodes and fiducial marker Practice of motor execution in Augmented Reality (AR) Gaming using phantom movements Practice of motor execution by matching random target postures of a virtual limb. Step 3 to 4 are repeated for different phantom joints, initially one at the time progressing to several joints simultaneously. A treatment session last 2 hours.

Intervention Type

Device

Intervention Name(s)

Phantom Motor Imagery

Other Intervention Name(s)

Neuromotus - PMI

Intervention Description

The only difference between PME and PMI is that in the former myoelectric signals are used to give the participants control over the virtual environments, whereas in PMI the presence of myoelectric activity is used as an alarm to remind the participant that it must imagine rather than execute the phantom movement. In PMI the virtual environments act autonomously to guide the participant in imagination of movement.

Primary Outcome Measure Information:

Title

Pain Rating Index registered at the beginning (1st session) and at the end of the treatment (15th session).

Description

Time Frame

28-40 weeks, depending on the frequency of the sessions.

Secondary Outcome Measure Information:

Title

Pain Disability Index registered at the beginning (1st session) and the end of the treatment (15th session).

Description

Time Frame

28-40 weeks, depending on the frequency of the sessions.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Max Ortiz Catalan, PhD

Organizational Affiliation

Chalmers Technological University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shirley Ryan Ability Lab

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Institue of Biomedical Engineering, University of New Brunswick

City

Fredericton

State/Province

New Brunswick

ZIP/Postal Code

E3B 5A3

Country

Canada

Facility Name

Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr - University Bochum (RUB)

City

Bochum

Country

Germany

Facility Name

School of Psychology, National University of Ireland

City

Galway

State/Province

Connacht

Country

Ireland

Facility Name

University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine

City

Groningen

ZIP/Postal Code

9700 RB

Country

Netherlands

Facility Name

University Rehabilitation Institute

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Ortopedteknik, Region Örebro län

City

Örebro

State/Province

Närke

ZIP/Postal Code

701 16

Country

Sweden

Facility Name

Bräcke Diakoni

City

Stockholm

State/Province

Uppland

ZIP/Postal Code

17078

Country

Sweden

Facility Name

Gåskolan, Ortopedtekniska avdelningen

City

Göteborg

State/Province

Västergötland

ZIP/Postal Code

41285

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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

background

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

background

PubMed Identifier

35152915

Citation

Lendaro E, Earley EJ, Ortiz-Catalan M. Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain. Trials. 2022 Feb 13;23(1):138. doi: 10.1186/s13063-021-05962-7.

Results Reference

derived

PubMed Identifier

30012784

Citation

Lendaro E, Hermansson L, Burger H, Van der Sluis CK, McGuire BE, Pilch M, Bunketorp-Kall L, Kulbacka-Ortiz K, Rigner I, Stockselius A, Gudmundson L, Widehammar C, Hill W, Geers S, Ortiz-Catalan M. Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial. BMJ Open. 2018 Jul 16;8(7):e021039. doi: 10.1136/bmjopen-2017-021039.

Results Reference

derived

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

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