Central brain responses of sacral nerve stimulation in patients with faecal incontinence

A prospective experimental study investigating the impact of sacral nerve stimulation on brain activity in patients with faecal incontinence

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12615001334594

Enrollment

Registered

2015-12-07

Start date

2015-01-15

Completion date

2015-09-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Sacral Nerve Stimulation(SNS) has revolutionised the management of urinary and faecal incontinence over the past 20 years. SNS is now embraced worldwide as a first line treatment for patients with urinary and faecal incontinence in whom conservative measures have failed. However, despite extensive experience with the stimulator and research in the field, its mechanism(s) of action remains elusive. Recently it has been suggested that SNS works by changing the way the brain functions by 'restarting' its normal function, akin to 'restarting a computer'. In this study we aim to lend scientific support for this hypothesis by investigating the impact of SNS on brain function using functional MRI (fMRI).

Interventions

This is an observational study, the exposure is acquisition of brain images using fMRI. Sacral nerve stimulator is a pacemaker like device implanted in the buttock and connected to leads that are placed in the S3 or S4 foramina percutaneously. fMRI involves acquisition of images whilst providing a visceral stimulus i.e. rectal balloon distension. This is performed at baseline and 6 weeks post device implantation.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age >18 years 2. Predominant symptom: Faecal Incontinence 3. Have no contraindications to MRI 4. Participants already scheduled to be treated by sacral nerve stimulation

Exclusion criteria

1. Non-English speaking 2. Cognitive impairment 3. CI to MRI e.g. claustrophobia 4. Major Psychological Disorders (eg. Major Depression, Major Anxiety, Schizophrenia, Bipolar) 4. Pregnancy 5. Neurological disorders e.g. Spina Bifida, Multiple Sclerosis, Parkinson disease.

Outcome results