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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03112928
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : March 11, 2022
Sponsor:
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

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).

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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

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:

  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.

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112928


Locations
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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
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Principal Investigator: Max Ortiz Catalan, PhD Chalmers Technological University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Integrum
ClinicalTrials.gov Identifier: NCT03112928    
Other Study ID Numbers: 007733
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain