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Phantom Limb PainNCT02281539

Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain

A study testing Neuromotus in people with Phantom Limb Pain, run by Integrum at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of the clinical investigation is to reduce phantom limb pain (PLP), painful condition affecting 70% of amputees, so as to improve these patients' quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Phantom Limb Pain
What is being tested?
Neuromotus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSweden
Study dates
Sep 2014to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Amputee patients older than 18 years.
  • The patient has signed a written informed consent.
  • Patients must have been treated with at least one of the following therapies:
  • Conventional mirror training
  • Transcutaneous electrical stimulation (TENS)
  • Acupuncture
Show all 11Show fewer
  • Self-hypnosis
  • Drug-based
  • The last session of previous therapies (1 and 2) must be at least 1 month before beginning the treatment here proposed.
  • In the case of drug-based treatments (5), the patient must report no PLP reduction for at least 1 month under the drug-based treatment and no variations on the medicaments dose. Any pain reduction potentially attributed to the drug-based treatment must be at least 3 months old.
  • At least a portion of biceps and triceps muscles must be present.

Who cannot join

  • Patient must not have a significant cognitive impairment that prevents them from following instructions.
  • Upper limb amputees excluding shoulder disarticulation.
  • Obese patient will not be automatically excluded, however, an evaluation in the system is required to analyse if sufficient electromyography signals can be recorded.
  • Stump pain over 2 VAS of pain.
  • Participating in any other clinical study that could interfere with the result in the ongoing study.
  • Condition associated with risk of poor protocol compliance.
  • Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgement.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Rehabilitation Center for Upper Limb Prosthetics

    Gothenburg

Other trials in Sweden

About this study

The goal of the clinical investigation is to reduce phantom limb pain (PLP), painful condition affecting 70% of amputees, so as to improve these patients' quality of life.

Read the detailed description

The goal of the clinical investigation is to reduce phantom limb pain (PLP), a painful condition affecting 70% of amputees, so as to improve these patients' quality of life. Traditionally, mirror box therapy and other tools based on the same concept, have been used to alleviate pain, but their efficacy varies greatly. This project targets amputees for whom other PLP treatments have failed. Various virtual environments, including virtual/augmented reality, are controlled by the patient's phantom limb using muscle (myoelectric) signals from the stump. The patient learns to reactivates areas in the brain related to motor control of the missing limb.

The medical device is non-invasive and based on surface electromyography, a standard and widely used clinical and research tool. The surface electrodes are a standard disposable electrodes widely used in clinics and hospitals for EMG and/or ECG.

  • Myoelectric amplifiers (battery operated and isolated from the power grid)
  • Data acquisition electronics
  • Personal computer
  • Standard webcam
  • Myoelectric pattern recognition (MPR) software
  • Virtual Reality (VR)
  • Augmented Reality (AR)
  • Computer game

The clinical investigation period consists of 12 sessions per patient including 3 short follow-up assessments. Length of the session: 1.5 hours (the first sessions can take longer time due to learning/familiarization). The centers participating in this study can choose between the following treatment administrations:

  • 2 times per week (advised)
  • 1 time per week
  • Daily (5 times per week)
Being tested
Neuromotus
Keywords
Phantom Limb Pain, Augmented Reality, Myoelectric control, Virtual reality, electromyography, pattern recognition, neurorehabilitation
Medical subject headings
Phantom Limb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeuromotusDevice

Study groups in NCT02281539
Study groupRoleWhat they receive
Treatment using myoelectric signalsExperimentalVirtual- and augmented reality, are controlled by the patient's phantom limb using muscle (myoelectric) signals from the stump. The patient learns to reactivate areas in the brain related to motor control of the missing limb. The medical device is non-invasive and based on surface electromyography
Receives: Device: Neuromotus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measuring the portion of patients that had a reduction of PLP according to the calculated weighted pain distribution (WPD)

    Each patient is asked to estimate the time spent in a given level of pain (as by VAS). The WPD is the sum of the portion of time multiplied with the pain level (0 to 5). This can also be explained as weighted mean calculation. The time with a given level of pain can be estimated in minutes/hours and extrapolated to its corresponding portion from the total time. Phantom Limb pain, which is a chronic pain, is difficult to describe can not be assesst in a single point in time. That is why patients are asked to fill in the amount of time they spend in each level of pain.

    Measured: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

Secondary outcomes (4)

  1. Descriptive analysis on the effect of the proposed treatment on quality of life, disability at the activity and participation levels.(DASH/COPM/EQ-5D)

    Questionnaires are answered before the first treatment and after the last treatment. Patients will also answer the questionnaires for a follow-up.

    Measured: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

  2. Measure the portion of patients that had a reduction of PLP with the use of visual analog scale and reduction on the "pain rating index".

    For the Pain Rating Index (PRI), each selected word is scored from 0 (none) to 5 (Excruciating pain). The total Pain Rating Index score is obtained by summing the item scores and higher score indicates worse pain.

    Measured: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

  3. Descriptive analysis on the effect of the proposed treatment in medicaments intake

    questionnaires compared

    Measured: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

  4. Patients having the same treatment administration will be classified in subgroups and their results compared.

    questionnaires compared

    Measured: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionSep 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02281539
Sponsor's protocol ID
PLP-004664
Status last verified
May 2016
First submitted
12 Oct 2014
Last updated
27 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24616655

  • 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.

    PubMed 27916234

Questions about this trial

What is this clinical trial studying?

A study testing Neuromotus in people with Phantom Limb Pain, run by Integrum at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring the portion of patients that had a reduction of PLP according to the calculated weighted pain distribution (WPD) (time frame: 12 treatment sessions (up to 12 weeks) + follow up (6months). Time frame will be total of 9 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02281539, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.

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