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

• ClinicalTrials.gov Identifier: NCT03112928
• Recruitment Status: Completed
• First Posted: April 13, 2017
• Last Update Posted: March 11, 2022
• 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
• Information provided by (Responsible Party): Integrum

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.

Condition or disease	Intervention/treatment	Phase
Phantom Limb Pain	Device: Phantom Motor Execution; Device: Phantom Motor Imagery	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: International, multi-centre, double-blind, randomized, controlled clinical trial
• Masking: Triple (Participant, Investigator, Outcomes 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.

• Primary Purpose: Treatment
• Official Title: Phantom Motor Execution Via Myoelectric Pattern Recognition, Virtual and Augmented Reality, and Serious Gaming as a Treatment of Phantom Limb Pain
• Actual Study Start Date: May 8, 2017
• Actual Primary Completion Date: March 12, 2021
• Actual Study Completion Date: September 20, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Phantom Motor Execution (PME); Phantom motor execution is decoded via myoelectric pattern recognition and promoted via serious gaming in virtual and augmented reality.	Device: Phantom Motor Execution; 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.; Other Name: Neuromotus - PME
Active Comparator: Phantom Motor Imagery (PMI); 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.	Device: Phantom Motor Imagery; 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.; Other Name: Neuromotus - PMI

Outcome Measures

Primary Outcome Measures :

1. Pain Rating Index registered at the beginning (1st session) and at the end of the treatment (15th session). [ Time Frame: 28-40 weeks, depending on the frequency of the sessions. ]
   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 :

1. Pain Disability Index registered at the beginning (1st session) and the end of the treatment (15th session). [ Time Frame: 28-40 weeks, depending on the frequency of the sessions. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Illinois

Shirley Ryan Ability Lab

Chicago, Illinois, United States, 60611

Canada, New Brunswick

Institue of Biomedical Engineering, University of New Brunswick

Fredericton, New Brunswick, Canada, E3B 5A3

Ireland

School of Psychology, National University of Ireland

Galway, Connacht, Ireland

Netherlands

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

Groningen, Netherlands, 9700 RB

Slovenia

University Rehabilitation Institute

Ljubljana, Slovenia, 1000

Sweden

Ortopedteknik, Region Örebro län

Örebro, Närke, Sweden, 701 16

Bräcke Diakoni

Stockholm, Uppland, Sweden, 17078

Gåskolan, Ortopedtekniska avdelningen

Göteborg, Västergötland, Sweden, 41285

Sponsors and Collaborators

Integrum

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

Investigators

• Principal Investigator: Max Ortiz Catalan, PhD; Chalmers Technological University

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Integrum
• ClinicalTrials.gov Identifier: NCT03112928
• Other Study ID Numbers: 007733
• First Posted: April 13, 2017
• Last Update Posted: March 11, 2022
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Phantom Limb; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain