- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03855930
Phantom Limb Pain Triggered by Micturition
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Motti Ratmansky, MD
- Phone Number: 9140 +972097709029
- Email: mottir@clalit.org.il
Study Contact Backup
- Name: Amir Haim, MD
- Phone Number: +972549765999
- Email: amirhaim@gmail.com
Study Locations
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Ra'anana, Israel, 43100
- Loewenstein Rehabilitation Center
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Raanana, Israel
- Loewenstein Rehabilitation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 |
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).
|
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
|
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).
|
healthy volunteers
10 healthy volunteers.
All patients will go through functional MRI study
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FMRI data analysis
Time Frame: 18 months
|
FMRI data analysis signifying, statistically significant uni-spatial voxel activity during micturition, in the study groups.
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Motti Ratmansky, MD, Loewenstein Rehabilitation Hospital
Publications and helpful links
General 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.
- Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.
- Shy 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0012-18-LOE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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