Phantom Limb PainNCT03855930
Phantom Limb Pain Triggered by Micturition
An observational study of Phantom Limb Pain, run by Loewenstein Hospital at 2 sites in Israel.
Trial summary
Phantom Limb Pain ( PLP) is pain that is perceived and referred to a region of the body that is no longer present. in most patients, severity and frequency of phantom pain attacks gradually decrease over several weeks to 2 years following amputation, however in 5-10% significant pain remains a serious problem. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- functional MRI
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- 25 Feb 2019to 2 Feb 2020
- Phase
- Observational
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. 10 Patients with chronic post amputation micturition induced PLP.All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria. 2. 10 Patients with chronic post amputation with PLP and without post amputation micturition induced PLP All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria. 3. 10 healthy volunteers
Who may be able to join
- 9 months or more post amputation, no anatomical stump pathology
- Ambulatory and to comply with study protocol
- Suffering from significant pain (VAS>??). pain level has plateaued for at lest 2 months prior to enrolment.
- Pain is perceived to be located in the missing limb
- Pain level is brought up or increases (by at least 3 VAS points) by micturition.
- Maneuvers causing abdominal pressure elevation do not generate similar symptoms.
- Subject received an explanation about the nature of the study and agrees to provide written informed consent
- Subject is capable and willing to follow all study-related procedures
Who cannot join
- Any condition inhibiting MRI study (e.g.Pacemakers or other implantable neurostimulators, ….)
- Subject has any condition, which precludes compliance with study instructions.
- Subject suffers from life threatening conditions
- Anatomical limitations that would prevent successful FMRI study
- Other medical conditions precluding FMRI study - e.g., claustrophobia
- Women gender- due to problematic usage of external urinating device during fMRI study
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Loewenstein Rehabilitation Center
Raanana, 43100
Loewenstein Rehabilitation Center
Raanana
About this study
Official title: Phantom Limb Pain Triggered by Micturition, An Functional Magnetic Resonance Imaging (FMRI) Study in Lower Limb Amputees
Phantom Limb Pain ( PLP) is pain that is perceived and referred to a region of the body that is no longer present. in most patients, severity and frequency of phantom pain attacks gradually decrease over several weeks to 2 years following amputation, however in 5-10% significant pain remains a serious problem.
It has been hypothesized, that deprivation of various inputs from the limbs to the brain cause an abnormal neuro-signature to be produced generating cortical maladaptive neuroplasticity and reorganization. Areas representing the amputated body part are taken over by neighboring representational zones in both the somatosensory and motor cortex generating pain in absence of stimuli.
Read more
A seminal paper published by Lotze et al "Phantom movements and pain: a functional magnetic resonance imaging (fMRI) study in upper limb amputees. - participants had to pucker their lips at a metronome-paced speed while functional magnetic resonance images were taken. Only in amputees with phantom-limb pain did a shift of the mouth representation into the hand representation occur; those without pain and the healthy control do not display a similar shift.
Scarce reports have been made on a similar phenomenon- micturition induced lower limb phantom pain.
We speculate that a similar maladaptive central nerve system (CNS) plasticity in which this genital representation would invade cortical areas with somatotopic affiliation to the lower extremity could be implicated in the pathophysiology of this phenomenon.
Read the detailed description
The present study was there for devised to examine this hypothesis utilizing fMRI imaging of temporo-spatial cortical activation during micturition and pain generation.
We hypothesis that in amputees with phantom-limb pain a shift of the genital representation into the leg representation will occur; and will be demonstrated as an uni-hemispheral activity on fMRI during micturition and pain suggesting maladaptive CNS plasticity. Moreover, we speculate that healthy volunteers will not display a similar shift.
During the study, standard motor and sensory paradigms will be performed to establish anatomical and functional patterns in the non-painful state. The patient will then be asked to urinate (to an external collecting tube system).
All anatomical data will be examined by a certified clinical imaging specialist to exclude concomitant brain pathology.
Study population -
- 10 Patients with chronic post amputation micturition induced PLP.All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria.
- 10 Patients with chronic post amputation with PLP and without post amputation micturition induced PLP All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria.
- 10 healthy volunteers
FMRI data analysis signifying, statistically significant uni-spatial voxel activity during micturition, in the study group
- Conditions
- Phantom Limb Pain
- Being tested
- functional MRI
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional MRIDiagnostic test
During the study, standard motor and sensory paradigms will be performed to establish anatomical and functional patterns in the non-painful state. The patient will then be asked to urinate (to an external collecting tube system).
| Study group | Role | What they receive |
|---|---|---|
| micturition induced PLP | 10 Patients with chronic post amputation micturition induced PLP.All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria.
All patients will go through functional MRI study Receives: Diagnostic Test: functional MRI | |
| non micturition induced PLP | 10 Patients with chronic post amputation with PLP and without post amputation micturition induced PLP All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria.All patients will go through functional MRI study Receives: Diagnostic Test: functional MRI | |
| healthy volunteers | 10 healthy volunteers. All patients will go through functional MRI study Receives: Diagnostic Test: functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMRI data analysis
FMRI data analysis signifying, statistically significant uni-spatial voxel activity during micturition, in the study groups.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start25 Feb 2019 (estimated)
- Primary completion2 Feb 2020 (estimated)
- Study completion2 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- Motti Ratmansky, MD, Principal investigator, Loewenstein Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855930
- Sponsor's protocol ID
- 0012-18-LOE
- Status last verified
- Jan 2019
- First submitted
- 25 Feb 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michels L, Blok BF, Gregorini F, Kurz M, Schurch B, Kessler TM, Kollias S, Mehnert U. Supraspinal Control of Urine Storage and Micturition in Men--An fMRI Study. Cereb Cortex. 2015 Oct;25(10):3369-80. doi: 10.1093/cercor/bhu140. Epub 2014 Jun 26.
PubMed 24969474Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.
PubMed 12849487Shy M, Fung S, Boone TB, Karmonik C, Fletcher SG, Khavari R. Functional magnetic resonance imaging during urodynamic testing identifies brain structures initiating micturition. J Urol. 2014 Oct;192(4):1149-54. doi: 10.1016/j.juro.2014.04.090. Epub 2014 Apr 21.
PubMed 24769029
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phantom Limb Pain Triggered by Micturition, An Functional Magnetic Resonance Imaging (FMRI) Study in Lower Limb Amputees
- ClinicalTrials.gov ID
- NCT03855930
- Acronym / sponsor ID
- 0012-18-LOE
- Conditions
- Phantom Limb Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 25 Feb 2019 (estimated)
- Primary completion
- 2 Feb 2020 (estimated)
- Study completion
- 2 Feb 2020 (estimated)
- First posted
- 27 Feb 2019 (actual)
- 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 pain that is perceived and referred to a region of the body that is no longer present. in most patients, severity and frequency of phantom pain attacks gradually decrease over several weeks to 2 years following amputation, however in 5-10% significant pain remains a serious problem.
It has been hypothesized, that deprivation of various inputs from the limbs to the brain cause an abnormal neuro-signature to be produced generating cortical maladaptive neuroplasticity and reorganization. Areas representing the amputated body part are taken over by neighboring representational zones in both the somatosensory and motor cortex generating pain in absence of stimuli.
A seminal paper published by Lotze et al "Phantom movements and pain: a functional magnetic resonance imaging (fMRI) study in upper limb amputees. - participants had to pucker their lips at a metronome-paced speed while functional magnetic resonance images were taken. Only in amputees with phantom-limb pain did a shift of the mouth representation into the hand representation occur; those without pain and the healthy control do not display a similar shift.
Scarce reports have been made on a similar phenomenon- micturition induced lower limb phantom pain.
We speculate that a similar maladaptive central nerve system (CNS) plasticity in which this genital representation would invade cortical areas with somatotopic affiliation to the lower extremity could be implicated in the pathophysiology of this phenomenon.
Detailed description
The present study was there for devised to examine this hypothesis utilizing fMRI imaging of temporo-spatial cortical activation during micturition and pain generation.
We hypothesis that in amputees with phantom-limb pain a shift of the genital representation into the leg representation will occur; and will be demonstrated as an uni-hemispheral activity on fMRI during micturition and pain suggesting maladaptive CNS plasticity. Moreover, we speculate that healthy volunteers will not display a similar shift.
During the study, standard motor and sensory paradigms will be performed to establish anatomical and functional patterns in the non-painful state. The patient will then be asked to urinate (to an external collecting tube system).
All anatomical data will be examined by a certified clinical imaging specialist to exclude concomitant brain pathology.
Study population -
- 10 Patients with chronic post amputation micturition induced PLP.All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria.
- 10 Patients with chronic post amputation with PLP and without post amputation micturition induced PLP All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria.
- 10 healthy volunteers
FMRI data analysis signifying, statistically significant uni-spatial voxel activity during micturition, in the study group
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| micturition induced PLP | – | Diagnostic Test: functional MRI10 Patients with chronic post amputation micturition induced PLP.All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria. All patients will go through functional MRI study |
| non micturition induced PLP | – | Diagnostic Test: functional MRI10 Patients with chronic post amputation with PLP and without post amputation micturition induced PLP All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria.All patients will go through functional MRI study |
| healthy volunteers | – | Diagnostic Test: functional MRI10 healthy volunteers. All patients will go through functional MRI study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. 10 Patients with chronic post amputation micturition induced PLP.All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria. 2. 10 Patients with chronic post amputation with PLP and without post amputation micturition induced PLP All subjects must fulfill all of the inclusion criteria and meet none of the exclusion criteria. 3. 10 healthy volunteers
Key inclusion criteria (8 listed)
- 9 months or more post amputation, no anatomical stump pathology
- Ambulatory and to comply with study protocol
- Suffering from significant pain (VAS>??). pain level has plateaued for at lest 2 months prior to enrolment.
- Pain is perceived to be located in the missing limb
- Pain level is brought up or increases (by at least 3 VAS points) by micturition.
Key exclusion criteria (6 listed)
- Any condition inhibiting MRI study (e.g.Pacemakers or other implantable neurostimulators, ….)
- Subject has any condition, which precludes compliance with study instructions.
- Subject suffers from life threatening conditions
- Anatomical limitations that would prevent successful FMRI study
- Other medical conditions precluding FMRI study - e.g., claustrophobia
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 |
|---|---|---|
| functional MRIDuring the study, standard motor and sensory paradigms will be performed to establish anatomical and functional patterns in the non-painful state. The patient will then be asked to urinate (to an external collecting tube system). | Diagnostic test | healthy volunteers, micturition induced PLP, non micturition induced PLP |
Primary outcome
FMRI data analysis
Time frame: 18 months
FMRI data analysis signifying, statistically significant uni-spatial voxel activity during micturition, in the study groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Results publication: PubMed 24969474Michels L, Blok BF, Gregorini F, Kurz M, Schurch B, Kessler TM, Kollias S, Mehnert U. Supraspinal Control of Urine Storage and Micturition in Men--An fMRI Study. Cereb Cortex. 2015 Oct;25(10):3369-80. doi: 10.1093/cercor/bhu140. Epub 2014 Jun 26.
- Results publication: PubMed 12849487Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.
- Results publication: PubMed 24769029Shy M, Fung S, Boone TB, Karmonik C, Fletcher SG, Khavari R. Functional magnetic resonance imaging during urodynamic testing identifies brain structures initiating micturition. J Urol. 2014 Oct;192(4):1149-54. doi: 10.1016/j.juro.2014.04.090. Epub 2014 Apr 21.
- Individual participant dataSharing planned: No
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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.
Motti Ratmansky, MD principal investigator
Loewenstein Rehabilitation Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phantom Limb Pain, run by Loewenstein Hospital at 2 sites in Israel.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Motti Ratmansky, MD (+972097709029 ext. 9140, mottir@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMRI data analysis (time frame: 18 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 NCT03855930, which also lists 3 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 Feb 2019.