Phantom Limb PainEPIONENCT02488668
Surface Electrical Stimulation for Treatment of Phantom Limb Pain
A study testing Surface Electrical Stimulation in people with Phantom Limb Pain, run by Winnie Jensen at 1 site in Denmark.
Trial summary
Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously difficult to treat. Amputation usually follows traumatic injuries or surgery following vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is required for the survival of the patient. 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?
- Surface Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2015to 1 Sep 2017
- 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
- Amputation of one or both arms below the shoulder level or amputation of one or both legs below hip joint
- Total or partial peripheral nerve injury (i.e.,under spinal cord level) causing paralysis of the arms or legs
- Other treatments for phantom limb pain should have been tried with poor results
- The subject should experience phantom limb pain at a level of 6 or higher measured on on a visual analog scale (VAS) ranging from 0-10
- Phantom limb pain should be experienced at least once a week
- The subject should be in a chronic and stable phase, and the stump should have healed
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- The subject should otherwise be healthy and able to carry out the experiment
- If pain medication is used it will be acceptable that the person continues to use the medication
- It should, through peripheral electrical stimulation, be possible to apply the relevant phantom emotions to the subject
Who cannot join
- Cognitive impairment
- Pregnancy
- Prior or current psychological diseases such as borderline, schizophrenia, depression or manic-depressive
- Acquired brain injury with residual impairment
- Prior neurological or musculoskeletal diseases
- History of or active substance abuse disorder
Show all 11Show fewer
- Persons with that experience an allergic reaction to surface electrodes
- Persons with fear for electrical stimulation or pain
- Persons that are hypersensitive to electrical stimulation and experience the stimulation as unpleasant
- Persons that feel may claustrophobic in an MRI scanner
- Persons that have metal parts in the body (such as pacemakers or metal screws)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural Sensory Feedback for Phantom Limb Modulation and Therapy
Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously difficult to treat. Amputation usually follows traumatic injuries or surgery following vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is required for the survival of the patient. The loss of a limb or other body parts is usually followed by the sensation that the lost body part is still present and can be felt. These phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well known that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic, psychological and other, are ineffective.
Today it is believed that phantom limb pain may be related to changes in the cortex of the brain. There is evidence that these changes may be modulated - or even reversed - by providing sensory input to the stump or amputation zone. For example, cortical reorganization and alleviation of phantom limb pain has been observed in amputees following intense use of a hand prosthesis. However, there is no consistent knowledge on which type of peripheral sensory feedback may be effective in affecting the cortical plasticity or on how to best apply the sensory feedback.
The aim of the proposed research is to create natural, meaningful sensations through providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.
Read the detailed description
Purpose of the experiment
Up to 50-80 % of persons with amputations experience pain in the part of the body that is missing. This phenomenon is called phantom limb pain. It is not clear today why phantom limb pain occurs, and since the pain can be difficult to treat, it can affect the quality of life. Other scientific studies have shown, that the use of electrical stimulation applied through surface electrodes, can assist to decrease or alleviate the phantom limb pain. The aim of this study is to investigate if daily surface electrical stimulation for a period of 30 days can decrease or alleviate the phantom limb pain.
Methods
Before the study begins, it will be necessary to test if the participant can tolerate the electrical stimulation and that the participant fulfill all criteria for participating in the study. During the study, different electrical stimulation sequences will be applied. The participant will be asked to fill out a series of questionnaires before, during and after the electrical stimulation, to describe how the electrical stimulation is experienced, and if the stimulation had an effect on the phantom limb pain and phantom sensations. The participant will also be asked about their general mood to investigate if this has an effect on the pain. The brain signals of the participants brain signals will be measured twice with either surface electrodes or with a scanning technique, while the participant is thinking about moving the amputated arm/hand or leg, while moving the healthy arm/leg, or while receiving electrical stimulation.
Plan for the experiment
The experiment will take place over a period of three months and consists of a series of measurement and intervention sessions planned in five phases. All sessions will take place at Aalborg University, Denmark except for the days when the brain signals are measured by using the scanning technique, which will take place at Aalborg University Hospital, Denmark.
Phase 1. Interview and meeting with the subject (before the experiment begins, 1 session, 1-2 hours). Before the experiment begins, the participant is invited to a meeting and interview with project responsible to inform the participant about the experiment.
Phase 2. Preliminary investigation (1 session of maximum 3 hours before the experiment starts). Before the experiment starts, but after the participant has signed the informed consent, the investigators will test if the participant can tolerate the electrical stimulation. If all criteria for participation are fulfilled, the participation of the subject will be decided.
Phase 3. Baseline measurements (day 1-27, 2 weekly sessions, maximum of 3 hours for each session). Before the repeated, electrical stimulation sessions begin, a series of baseline measurements will be performed. In this phase the sensory threshold (i.e., the level of the electrical stimulation that you can feel) will be measured, and the electrical stimulation parameters determined. The brain signals of the participant will be measured by a scanning technique (so-called functional magnetic resonance imaging or fMRI) and by surface electrodes placed oh the scalp (so-called electroencephalographic recordings or EEG). On the day that the brain signals are measured the session may last up to 5 hours.
Phase 4. Intervention period (day 28-56, 2-5 weekly sessions, maximum of 3 hours for each session). In these sessions, electrical stimulation will be applied through surface electrodes placed on the upper arm/the stump or the leg. The participant will be asked to fill out a series of questionnaires to report on the phantom limb pain, phantom sensations (i.e., non-painful sensations) and their general mood. Again the participant's brain signals will be measured using the scanning and the surface electrode techniques. On the day that the brain signals are measured the session may last up to 5 hours.
Phase 5. Follow-up (day 57-112, 4 weekly session over 8 weeks of maximum 3 hours). To measure the effect and duration of the intervention the participant will be asked to fill out a series of questionnaires.
Risks, side effects and disadvantages
Surface stimulation may cause muscle-contractions. Attachment of the surface electrodes may cause the skin to become red or irritated for some hours following the experiment. The type of electrical stimulation used in this experiment is not associated with any known risks or side effects. When the sensory threshold is determined (i.e., the lowest strength of the electrical stimulation that the participant can feel), it may feel unpleasant or painful for a short period of time, but the unpleasantness or pain will disappear as soon as the electrical stimulation stops. The electrical stimulation applied during the intervention period will be adjusted such that is it not painful.
Measurement of the brain signals using the fMRI-technique (scanning) is safe, and there are no known risks or side effects of this procedure. The participant may, however, find that being placed inside the scanner is unpleasant. Measurement of the brain signals with surface electrodes is also considered safe, and there are no known risks or side effects of this procedure. There may be risks associated with the experiment that are unknown to the investigators. Therefore, the participant is asked to inform the investigators if the participant experiences any health problems during the experiment. If the investigators discover any side effects, the participant will be informed immediately.
Benefits of the experiment
There will be no benefits for the subject by participation in the study. However, the participant may find that his/her phantom limb pain is alleviated during the experiment as a result of the electrical stimulation. However, it is not possible for the investigators to predict if the electrical stimulation will affect the phantom limb pain, when the effect will start, how large the effect will be, or how long the effect will last. It is not possible to offer the participants a permanent or lasting solution after termination of the study.
Exclusion from and suspension of the experiment
If the participant, according to the assessment of the investigator, react unexpectedly on the procedures or in any other way are not suitable for continuing in the experiment, the participation in the experiment can be terminated at any time. In general, the experiment will be terminated if it turns out that the subjects in general cannot tolerate the procedures of the project or find the experiment too exhausting.
- Conditions
- Phantom Limb Pain
- Being tested
- Surface Electrical Stimulation
- Keywords
- Transcutaneous Electrical Stimulation, Neuroplasticity, Sensory Feedback
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Electrical StimulationDevice
Surface electrical stimulation using the following devices; 1) INOMED surface stimulator, 2) The EPIONE Psychophysical Testing Platform software for stimulator control. Surface stimulation therapy is provided while providing visual guidance to the subject.
| Study group | Role | What they receive |
|---|---|---|
| Surface Electrical Stimulation | Experimental | Please see information under 'Detailed description' Receives: Device: Surface Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phantom limb pain
The pain intensity will be assessed using a visual analog scale (VAS)
Measured: Change in pain perception over three months
Cortical reorganization
The cortical response to peripheral stimulation will be tracked using MRI
Measured: Change in cortical reorganization over three months
Secondary outcomes (2)
Cortical reorganization
The cortical response to peripheral stimulation will be tracked using EEG
Measured: Change in cortical reorganization over three months
Phantom limb pain
The pain symptoms wil be assessed using the neuropathic pain symptom inventory (NPSI)
Measured: Change in neuropathic pain symptoms over three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2015
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Winnie Jensen
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, University of Lausanne Hospitals, University of Freiburg, Université Montpellier, Lund University, Indiana University, Novosense AB, Mxm-Obelia, Ecole Polytechnique Fédérale de Lausanne, Universitat Autonoma de Barcelona, Catholic University of the Sacred Heart
- Responsible party
- Sponsor-investigator, Winnie Jensen, Aalborg University
- Investigators
- Winnie Jensen, Ph.D, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488668
- Sponsor's protocol ID
- EPIONE-602547-1
- Other IDs
- 602547
- Acronym
- EPIONE
- Status last verified
- Nov 2017
- First submitted
- 30 Jun 2015
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Sensory Feedback for Phantom Limb Modulation and Therapy
- ClinicalTrials.gov ID
- NCT02488668
- Acronym / sponsor ID
- EPIONE / EPIONE-602547-1
- Conditions
- Phantom Limb Pain
- Keywords
- Transcutaneous Electrical Stimulation, Neuroplasticity, Sensory Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Winnie JensenUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, University of Lausanne Hospitals, University of Freiburg, Université Montpellier, Lund University, Indiana University, Novosense AB, Mxm-Obelia, Ecole Polytechnique Fédérale de Lausanne, Universitat Autonoma de Barcelona, Catholic University of the Sacred Heart
- Study start
- Jun 2015
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously difficult to treat. Amputation usually follows traumatic injuries or surgery following vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is required for the survival of the patient. The loss of a limb or other body parts is usually followed by the sensation that the lost body part is still present and can be felt. These phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well known that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic, psychological and other, are ineffective.
Today it is believed that phantom limb pain may be related to changes in the cortex of the brain. There is evidence that these changes may be modulated - or even reversed - by providing sensory input to the stump or amputation zone. For example, cortical reorganization and alleviation of phantom limb pain has been observed in amputees following intense use of a hand prosthesis. However, there is no consistent knowledge on which type of peripheral sensory feedback may be effective in affecting the cortical plasticity or on how to best apply the sensory feedback.
The aim of the proposed research is to create natural, meaningful sensations through providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.
Detailed description
Purpose of the experiment
Up to 50-80 % of persons with amputations experience pain in the part of the body that is missing. This phenomenon is called phantom limb pain. It is not clear today why phantom limb pain occurs, and since the pain can be difficult to treat, it can affect the quality of life. Other scientific studies have shown, that the use of electrical stimulation applied through surface electrodes, can assist to decrease or alleviate the phantom limb pain. The aim of this study is to investigate if daily surface electrical stimulation for a period of 30 days can decrease or alleviate the phantom limb pain.
Methods
Before the study begins, it will be necessary to test if the participant can tolerate the electrical stimulation and that the participant fulfill all criteria for participating in the study. During the study, different electrical stimulation sequences will be applied. The participant will be asked to fill out a series of questionnaires before, during and after the electrical stimulation, to describe how the electrical stimulation is experienced, and if the stimulation had an effect on the phantom limb pain and phantom sensations. The participant will also be asked about their general mood to investigate if this has an effect on the pain. The brain signals of the participants brain signals will be measured twice with either surface electrodes or with a scanning technique, while the participant is thinking about moving the amputated arm/hand or leg, while moving the healthy arm/leg, or while receiving electrical stimulation.
Plan for the experiment
The experiment will take place over a period of three months and consists of a series of measurement and intervention sessions planned in five phases. All sessions will take place at Aalborg University, Denmark except for the days when the brain signals are measured by using the scanning technique, which will take place at Aalborg University Hospital, Denmark.
Phase 1. Interview and meeting with the subject (before the experiment begins, 1 session, 1-2 hours). Before the experiment begins, the participant is invited to a meeting and interview with project responsible to inform the participant about the experiment.
Phase 2. Preliminary investigation (1 session of maximum 3 hours before the experiment starts). Before the experiment starts, but after the participant has signed the informed consent, the investigators will test if the participant can tolerate the electrical stimulation. If all criteria for participation are fulfilled, the participation of the subject will be decided.
Phase 3. Baseline measurements (day 1-27, 2 weekly sessions, maximum of 3 hours for each session). Before the repeated, electrical stimulation sessions begin, a series of baseline measurements will be performed. In this phase the sensory threshold (i.e., the level of the electrical stimulation that you can feel) will be measured, and the electrical stimulation parameters determined. The brain signals of the participant will be measured by a scanning technique (so-called functional magnetic resonance imaging or fMRI) and by surface electrodes placed oh the scalp (so-called electroencephalographic recordings or EEG). On the day that the brain signals are measured the session may last up to 5 hours.
Phase 4. Intervention period (day 28-56, 2-5 weekly sessions, maximum of 3 hours for each session). In these sessions, electrical stimulation will be applied through surface electrodes placed on the upper arm/the stump or the leg. The participant will be asked to fill out a series of questionnaires to report on the phantom limb pain, phantom sensations (i.e., non-painful sensations) and their general mood. Again the participant's brain signals will be measured using the scanning and the surface electrode techniques. On the day that the brain signals are measured the session may last up to 5 hours.
Phase 5. Follow-up (day 57-112, 4 weekly session over 8 weeks of maximum 3 hours). To measure the effect and duration of the intervention the participant will be asked to fill out a series of questionnaires.
Risks, side effects and disadvantages
Surface stimulation may cause muscle-contractions. Attachment of the surface electrodes may cause the skin to become red or irritated for some hours following the experiment. The type of electrical stimulation used in this experiment is not associated with any known risks or side effects. When the sensory threshold is determined (i.e., the lowest strength of the electrical stimulation that the participant can feel), it may feel unpleasant or painful for a short period of time, but the unpleasantness or pain will disappear as soon as the electrical stimulation stops. The electrical stimulation applied during the intervention period will be adjusted such that is it not painful.
Measurement of the brain signals using the fMRI-technique (scanning) is safe, and there are no known risks or side effects of this procedure. The participant may, however, find that being placed inside the scanner is unpleasant. Measurement of the brain signals with surface electrodes is also considered safe, and there are no known risks or side effects of this procedure. There may be risks associated with the experiment that are unknown to the investigators. Therefore, the participant is asked to inform the investigators if the participant experiences any health problems during the experiment. If the investigators discover any side effects, the participant will be informed immediately.
Benefits of the experiment
There will be no benefits for the subject by participation in the study. However, the participant may find that his/her phantom limb pain is alleviated during the experiment as a result of the electrical stimulation. However, it is not possible for the investigators to predict if the electrical stimulation will affect the phantom limb pain, when the effect will start, how large the effect will be, or how long the effect will last. It is not possible to offer the participants a permanent or lasting solution after termination of the study.
Exclusion from and suspension of the experiment
If the participant, according to the assessment of the investigator, react unexpectedly on the procedures or in any other way are not suitable for continuing in the experiment, the participation in the experiment can be terminated at any time. In general, the experiment will be terminated if it turns out that the subjects in general cannot tolerate the procedures of the project or find the experiment too exhausting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surface Electrical Stimulation | Experimental | Device: Surface Electrical StimulationPlease see information under 'Detailed description' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Amputation of one or both arms below the shoulder level or amputation of one or both legs below hip joint
- Total or partial peripheral nerve injury (i.e.,under spinal cord level) causing paralysis of the arms or legs
- Other treatments for phantom limb pain should have been tried with poor results
- The subject should experience phantom limb pain at a level of 6 or higher measured on on a visual analog scale (VAS) ranging from 0-10
- Phantom limb pain should be experienced at least once a week
Key exclusion criteria (11 listed)
- Cognitive impairment
- Pregnancy
- Prior or current psychological diseases such as borderline, schizophrenia, depression or manic-depressive
- Acquired brain injury with residual impairment
- Prior neurological or musculoskeletal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface Electrical StimulationSurface electrical stimulation using the following devices; 1) INOMED surface stimulator, 2) The EPIONE Psychophysical Testing Platform software for stimulator control. Surface stimulation therapy is provided while providing visual guidance to the subject. | Device | Surface Electrical Stimulation |
Primary outcome
Phantom limb pain
Time frame: Change in pain perception over three months
The pain intensity will be assessed using a visual analog scale (VAS)
Cortical reorganization
Time frame: Change in cortical reorganization over three months
The cortical response to peripheral stimulation will be tracked using MRI
2 secondary outcomes
Cortical reorganization
Time frame: Change in cortical reorganization over three months
Phantom limb pain
Time frame: Change in neuropathic pain symptoms over three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winnie Jensen, Ph.D principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface Electrical Stimulation in people with Phantom Limb Pain, run by Winnie Jensen at 1 site in Denmark.
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 9 inclusion and 11 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 14 Nov 2017. 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 Denmark. 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?
Phantom limb pain (time frame: Change in pain perception over three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2017.