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

NCT03112928 | Completed

• 1 other identifier: 007733
• Study Type: interventional
• Target: 77
• Locations: 7 countries
• Sites: 9

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.

Conditions

Phantom Limb Pain

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

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

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

Study Arms (2)

Phantom Motor Execution (PME)

EXPERIMENTAL

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

Device: Phantom Motor Execution

Phantom Motor Imagery (PMI)

ACTIVE COMPARATOR

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

Interventions

Phantom Motor Execution DEVICE

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: 1. Pain evaluation 2. Placement of the electrodes and fiducial marker 3. Practice of motor execution in Augmented Reality (AR) 4. Gaming using phantom movements 5. 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.

Also known as: Neuromotus - PME

Phantom Motor Execution (PME)

Phantom Motor Imagery DEVICE

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.

Also known as: Neuromotus - PMI

Phantom Motor Imagery (PMI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (9)

Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

Location

Institue of Biomedical Engineering, University of New Brunswick

Fredericton, New Brunswick, E3B 5A3, Canada

Location

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

Bochum, Germany

Location

School of Psychology, National University of Ireland

Galway, Connacht, Ireland

Location

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

Groningen, 9700 RB, Netherlands

Location

University Rehabilitation Institute

Ljubljana, 1000, Slovenia

Location

Ortopedteknik, Region Örebro län

Örebro, Närke, 701 16, Sweden

Location

Bräcke Diakoni

Stockholm, Uppland, 17078, Sweden

Location

Gåskolan, Ortopedtekniska avdelningen

Gothenburg, Västergötland, 41285, Sweden

Location

Related Publications (5)

• 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.

  PMID: 27916234 BACKGROUND

• 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.

  PMID: 24616655 BACKGROUND

• Lendaro E, Van der Sluis CK, Hermansson L, Bunketorp-Kall L, Burger H, Keesom E, Widehammar C, Munoz-Novoa M, McGuire BE, O'Reilly P, Earley EJ, Iqbal S, Kristoffersen MB, Stockselius A, Gudmundson L, Hill W, Diers M, Turner KL, Weiss T, Ortiz-Catalan M. Extended reality used in the treatment of phantom limb pain: a multicenter, double-blind, randomized controlled trial. Pain. 2025 Mar 1;166(3):571-586. doi: 10.1097/j.pain.0000000000003384. Epub 2024 Sep 5.

  PMID: 39250328 DERIVED

• 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.

  PMID: 35152915 DERIVED

• 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.

  PMID: 30012784 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Max Ortiz Catalan, PhD

  Chalmers Technological University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: International, multi-centre, double-blind, randomized, controlled clinical trial

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: May 8, 2017
• Primary Completion: March 12, 2021
• Study Completion: September 20, 2021
• Last Updated: June 22, 2023

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); IE (1); NL (1); SL (1); US (1); SE (3); DE (1)