Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to determine whether Sacral Nerve Stimulation (SNS) for idiopathic faecal incontinence affect cortical and deep brain activity in an acute and chronically stimulation model. Furthermore the association between brain activity and unilateral/bilateral SNS will be studied in each patient. Brain activity will be studied by use of positron emission tomography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 22, 2010
CompletedFirst Posted
Study publicly available on registry
March 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 4, 2014
March 1, 2012
2.5 years
March 22, 2010
July 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Regional Cerebral Blood Flow with different pacemaker settings
RCBF evaluated with positron emission tomography.
12 weeks after study enrolment
Secondary Outcomes (1)
Changes in continence and quality of life with different pacemaker activation.
12 weeks after study enrolment
Study Arms (3)
Off/Off
EXPERIMENTALPacemaker status: Bilateral Off for four weeks before first PET scann.
On/On
EXPERIMENTALPacemaker status: Bilateral On. PET scan one hour after activation and after four weeks continuous stimulation.
On/Off
EXPERIMENTALPacemaker status: Unilateral On. PET scan one hour after activation and after four weeks continuous stimulation.
Interventions
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, 8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jakob K Jakobsen, MD.
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2010
First Posted
March 29, 2010
Study Start
February 1, 2010
Primary Completion
August 1, 2012
Study Completion
July 1, 2014
Last Updated
July 4, 2014
Record last verified: 2012-03