Phantom Limb PainEPIONENCT02506608
Use of Hand Prosthesis With Direct Nerve Stimulation for Treatment of Phantom Limb Pain
A study testing Operation of sensorized hand prosthesis in people with Phantom Limb Pain, run by Paolo Maria Rossini at 1 site in Italy.
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?
- Operation of sensorized hand prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to 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
- Uni-lateral amputation below the shoulder level
- 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 leaste once a week
- The subject should be in a chronica and stable phase, and the stump should have healed
- 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
Who cannot join
- Cognitive impairment
- Pregnancy
- Prior or current psychological diseases such as borderline, schizophrenia, depression or maniodepression
- Acquired brain injury with residual impairment
- Prior neurological or muscoloskeletal diseases
- History of or active substance abuse disorder
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- Excessive sensitivity to electrical stimulation with surface electrodes
- Persons with fear for electrical stimulation, pain cannot participate
- Persons that are hypersensitive to electrical stimulation and experience the stimulation as unpleasent cannot participate
- Since the protocol includes MRI scanning of the brain, persons that may feel claustrophobic cannot participate
- Since the protocol includes MRI scanning of the brain, persons that have metal parts in the body (such as pacemakers or bone-screws) cannot participate
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 sensory feedback (i.e. surface or neural electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.
- Conditions
- Phantom Limb Pain
- Being tested
- Operation of sensorized hand prosthesis
- Keywords
- Neuroplasticty, 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.
Operation of sensorized hand prosthesisProcedure or surgery
Four TIME-4H electrodes will be implanted in the median and ulnar of the amputees. The electrodes will be connected with the STIMEP electrical multichannel stimulator. The stimulator will be connected with one of the sensorized prostheses. Afferent and efferent signals will be elaborated and integrated by the ODROID software.
The amputees will be able to control the prostheses movement and receive a sensory feedback from the prosthesis sensors.
The use of the prosthesis during different tasks will be considered the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Operation of sensorized hand prosthesis | Experimental | A system composed by the integration of the following non-CE marked medical devices specifically designed for the study will be used in amputees:
* STIMEP (multichannel electrical stimulator for the peripheral nervous system; AXONIC)
* TIME 4H Intraneural Electrodes (ALBERT-LUDWIGS-UNIVERSITAET FREIBURG)
* Sensorized hand Prosthetics for amputees IH2 Prosthetic Azurra Prensilia (Prensilia Ltd.)
* Prosthetics sensorized hand for amputees DLR / HIT Hand II (Wessling Robotics)
* ODROID software integration within the afferent and efferent bi-directional control of the robotic hand Receives: Procedure: Operation of sensorized hand prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phantom limb pain
Questionnaires (Visual Analogic Scale, Neuropathic Pain Symptom Inventory )
Measured: Change in Phantom Limb Pain daily during the whole study (maximum 1 year per patient)
Cortical reorganization
Electroencephalography; Transcranial Magnetic Stimulation and electroencephalography; functional Magnetic Resonance Imaging; Transcranial Magnetic Stimulation ; Somatosensory Evoked Potentials
Measured: Change in Cortical reorganization before and at the end of 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completionSep 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paolo Maria Rossini
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Aalborg University, 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
- Responsible party
- Sponsor-investigator, Paolo Maria Rossini, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506608
- Sponsor's protocol ID
- EPIONE-602547-6
- Other IDs
- no. 602547
- Acronym
- EPIONE
- Status last verified
- Dec 2017
- First submitted
- 20 Jul 2015
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 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
- NCT02506608
- Acronym / sponsor ID
- EPIONE / EPIONE-602547-6
- Conditions
- Phantom Limb Pain
- Keywords
- Neuroplasticty, Sensory Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Paolo Maria RossiniUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Aalborg University, 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
- Study start
- Jun 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 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 sensory feedback (i.e. surface or neural electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operation of sensorized hand prosthesis | Experimental | Procedure: Operation of sensorized hand prosthesisA system composed by the integration of the following non-CE marked medical devices specifically designed for the study will be used in amputees: * STIMEP (multichannel electrical stimulator for the peripheral nervous system; AXONIC) * TIME 4H Intraneural Electrodes (ALBERT-LUDWIGS-UNIVERSITAET FREIBURG) * Sensorized hand Prosthetics for amputees IH2 Prosthetic Azurra Prensilia (Prensilia Ltd.) * Prosthetics sensorized hand for amputees DLR / HIT Hand II (Wessling Robotics) * ODROID software integration within the afferent and efferent bi-directional control of the robotic hand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Uni-lateral amputation below the shoulder level
- 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 leaste once a week
- The subject should be in a chronica and stable phase, and the stump should have healed
Key exclusion criteria (11 listed)
- Cognitive impairment
- Pregnancy
- Prior or current psychological diseases such as borderline, schizophrenia, depression or maniodepression
- Acquired brain injury with residual impairment
- Prior neurological or muscoloskeletal 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 |
|---|---|---|
| Operation of sensorized hand prosthesisFour TIME-4H electrodes will be implanted in the median and ulnar of the amputees. The electrodes will be connected with the STIMEP electrical multichannel stimulator. The stimulator will be connected with one of the sensorized prostheses. Afferent and efferent signals will be elaborated and integrated by the ODROID software. The amputees will be able to control the prostheses movement and receive a sensory feedback from the prosthesis sensors. The use of the prosthesis during different tasks will be considered the intervention. | Procedure or surgery | Operation of sensorized hand prosthesis |
Primary outcome
Phantom limb pain
Time frame: Change in Phantom Limb Pain daily during the whole study (maximum 1 year per patient)
Questionnaires (Visual Analogic Scale, Neuropathic Pain Symptom Inventory )
Cortical reorganization
Time frame: Change in Cortical reorganization before and at the end of 1 year of treatment
Electroencephalography; Transcranial Magnetic Stimulation and electroencephalography; functional Magnetic Resonance Imaging; Transcranial Magnetic Stimulation ; Somatosensory Evoked Potentials
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 6 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operation of sensorized hand prosthesis in people with Phantom Limb Pain, run by Paolo Maria Rossini at 1 site in Italy.
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 7 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 6 Dec 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 Italy. 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 Phantom Limb Pain daily during the whole study (maximum 1 year per patient)). 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 6 Dec 2017.