- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01095029
Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence
Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence - Assessed With Positron Emission Tomography Scan (PET-scan)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Faecal incontinence is a devastating condition affecting daily living and quality of life. A new treatment Sacral Nerve Stimulation (SNS) has over the last decade given new hope to these patients. In Europe SNS is routinely offered to patients not archiving satisfactory continence result with standard non-surgical treatments. SNS is electrical stimulation of the sacral nerve root(s2,3 or 4). Stimulation of this nerve roots results in improved continence. The mechanism of action is at present not well described. Recent studies have shown that the effect of SNS is by means a neuromodulation in the central nervous system, whereas direct stimulation of efferent nerves to the anal sphincter and the pelvic floor has less significance.
The aim of this study is to describe changes in regional cerebral blood flow (RCBF), with positron emission tomography (PET), in patients implanted bilaterally with sacral neuromodulators with the indication idiopathic faecal incontinence.
RCBF in three deferent stimulations settings will be compared. PET will be performed before and one hour after changes in the activity status of the pacemakers. Four weeks prior to the first scan, patients are informed to switch both neurostimulator off. PET will be performed with the pacemaker settings: OFF/OFF (Stimulation status of left/right pacemaker), On/Off and On/On. The order of the On/OFF and On/On period will be random. Unilateral stimulation will be performed with the pacemaker there has the best efficacy, determined prior to study enrolment. The interval between these three pacemaker settings is four weeks. Four weeks prior to each PET scan the patients fill in bowel habit diaries, bowel habit questionnaires and quality of life assessments.
The association between continence and changes in RCBF will be studied. Additional RCBF and quality of life will be compared.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aarhus C
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Aarhus, Aarhus C, Denmark, 8000
- Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older
- Informed consent
- Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
- Permanent neuromodulator (medtronic InterStim II) bilateral implanted
- Reduction in fecal incontinence episodes of at least 50% between baseline and latest follow up with unilateral stimulation(Bowel diary card)
- Willing and competent to fill out diary cards
- MR-cerebrum before implantatation of neuromodulator
- Right-handed dominant
Exclusion Criteria:
- Colorectal/proctological surgery since IPG-implant
- Pregnancy
- Neurological diseases including spinal cord injury.
- Use of medication with known alternation of gastrointestinal motilitet (thyroid, diabetes, neuroleptica)
- Claustrofobia
- Latex allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Off/Off
Pacemaker status: Bilateral Off for four weeks before first PET scann.
|
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
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EXPERIMENTAL: On/On
Pacemaker status: Bilateral On.
PET scan one hour after activation and after four weeks continuous stimulation.
|
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
|
EXPERIMENTAL: On/Off
Pacemaker status: Unilateral On.
PET scan one hour after activation and after four weeks continuous stimulation.
|
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Regional Cerebral Blood Flow with different pacemaker settings
Time Frame: 12 weeks after study enrolment
|
RCBF evaluated with positron emission tomography.
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12 weeks after study enrolment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in continence and quality of life with different pacemaker activation.
Time Frame: 12 weeks after study enrolment
|
Changes in incontinence episodes and quality of life will be correlated to changes in RCBF with different pacemaker activation.
|
12 weeks after study enrolment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jakob K Jakobsen, MD., Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 003 (NuSkin International)
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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