Clinical trial NCT03112928: 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
Overall status: COMPLETED
Phase: NA
Conditions: Phantom Limb Pain
Lead sponsor: Integrum
Sponsor class: INDUSTRY
Collaborators: name: Chalmers University of Technology
name: Sahlgrenska University Hospital
name: Örebro University, Sweden
name: Bräcke Diakoni, Sweden
name: University Rehabilitation Institute, Republic of Slovenia
name: University Medical Center Groningen
name: University of New Brunswick
name: National University of Ireland, Galway, Ireland
name: Shirley Ryan AbilityLab
name: Ruhr University of Bochum
First posted: 2017-04-13
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: International, multi-centre, double-blind, randomized, controlled clinical trial
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Pain Rating Index registered at the beginning (1st session) and at the end of the treatment (15th session).
timeFrame: 28-40 weeks, depending on the frequency of the sessions.
Secondary outcomes:
measure: Pain Disability Index registered at the beginning (1st session) and the end of the treatment (15th session).
timeFrame: 28-40 weeks, depending on the frequency of the sessions.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan Ability Lab
state: Illinois
city: Fredericton
country: Canada
facility: Institue of Biomedical Engineering, University of New Brunswick
state: New Brunswick
city: Bochum
country: Germany
facility: Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr - University Bochum (RUB)
city: Galway
country: Ireland
facility: School of Psychology, National University of Ireland
state: Connacht
city: Groningen
country: Netherlands
facility: University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute
city: Örebro
country: Sweden
facility: Ortopedteknik, Region Örebro län
state: Närke
city: Stockholm
country: Sweden
facility: Bräcke Diakoni
state: Uppland
city: Göteborg
country: Sweden
facility: Gåskolan, Ortopedtekniska avdelningen
state: Västergötland
Study officials:
affiliation: Chalmers Technological University
name: Max Ortiz Catalan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.