Computational Model of SNS (Sacral Nerve Stimulation) Induced Electrical Current Flow Using Tractography Imaging

NCT05049486 | Completed

• 1 other identifier: London North West NHS Trust
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high-resolution anatomical MRI sequences and diffusion tensor imaging (DTI). DTI is a non-invasive technique sometimes described as fiber tractography that enables visualization of the pathways and integrity of nerves. In this feasibility study, we plan to use DTI to assess the sacral plexus and its peripheral nerves. A model will be constructed by superimposing SNS lead from a CT scan onto the DTI imaging to map out the electrode position. It is hoped that this study will lead to a better understanding of both therapeutic and adverse stimulation effects and enable patient-specific adjustments of stimulation parameters.

Conditions

Faecal Incontinence

Keywords

Sacral Nerve Stimulator;; DTI;; MRI;; Faecal Incontinence;; CT scan;

Outcome Measures

Primary Outcomes (1)

• Implanting a lead around a nerve for finer details of tissues surrounding a sacral nerve stimulation lead.

  Size and distance of the sacral nerves from the implanted lead measured in millimetres (mm).

  12 months

Secondary Outcomes (1)

• Stimulation of the sacral nerve using computational model induced electrical current to establish therapeutic range of SNS

  12 months

Study Arms (2)

MRI sequences and (DTI)

NO INTERVENTION

The aim of this study is to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high resolution anatomical MRI sequences and diffusion tensor imaging (DTI). To do so, the patient will undergo a MRI scan (3 Tesla) of the pelvis using sequences including anatomical sequences and diffusion tensor imaging technique for construction of sacral nerve tractography prior to permanent SNS. This will be performed over an hour: first 30 minutes for anatomical sequences and the second 30 minutes for DTI sequencing.

CT scan

ACTIVE COMPARATOR

Three to 4 weeks after the procedure the patient will undergo a limited CT scan of the pelvis to visualise the position of the SNS lead. The scan will focus only on the sacrum, implanted lead, and rectum and will not be extended beyond this area. Imaging from this CT will be superimposed to the MRI imaging the patient had pre-operatively, and a computational simulation will be performed.

Radiation: CT scan

Interventions

CT scan RADIATION

Patients will undergone a pelvic CT scan.

CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are psychologically stable and suitable for intervention and able to provide informed consent
• Patients with symptoms of faecal incontinence for solid or liquid stool
• Patients who have had successful outcome from temporary SNS
• Patients who are willing and competent to fill in questionnaires and undergo an extra CT and MRI scan during the study

You may not qualify if:

• Patients who are claustrophobic to undertake MRI scan
• Patients who had previous devices implanted that may be magnetically, electrically, mechanically activated or affected by MRI scan
• Pregnant patients
• Patients who are breastfeeding
• Patients who are psychologically unstable and unsuitable for intervention and unable to provide informed consent
• Patients who did not successfully pass the trial of SNS temporary SNS)

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead
• Medtronic: collaborator

Study Sites (1)

London North West NHS Trust

Harrow, HA1 3UJ, United Kingdom

Location

Related Publications (6)

• Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.

  PMID: 8416784 BACKGROUND

• Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.

  PMID: 9862829 BACKGROUND

• Maeda Y, Lundby L, Buntzen S, Laurberg S. Outcome of sacral nerve stimulation for fecal incontinence at 5 years. Ann Surg. 2014 Jun;259(6):1126-31. doi: 10.1097/SLA.0b013e31829d3969.

  PMID: 23817505 RESULT

• Maeda Y, Lundby L, Buntzen S, Laurberg S. Suboptimal outcome following sacral nerve stimulation for faecal incontinence. Br J Surg. 2011 Jan;98(1):140-7. doi: 10.1002/bjs.7302. Epub 2010 Oct 27.

  PMID: 21136568 RESULT

• van der Jagt PK, Dik P, Froeling M, Kwee TC, Nievelstein RA, ten Haken B, Leemans A. Architectural configuration and microstructural properties of the sacral plexus: a diffusion tensor MRI and fiber tractography study. Neuroimage. 2012 Sep;62(3):1792-9. doi: 10.1016/j.neuroimage.2012.06.001. Epub 2012 Jun 13.

  PMID: 22705377 RESULT

• Cotterill N, Norton C, Avery KN, Abrams P, Donovan JL. A patient-centered approach to developing a comprehensive symptom and quality of life assessment of anal incontinence. Dis Colon Rectum. 2008 Jan;51(1):82-7. doi: 10.1007/s10350-007-9069-3. Epub 2007 Nov 15.

  PMID: 18008106 RESULT

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Carolynne Vaizey, FRCS

  London North West NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: September 20, 2021
• Study Start: October 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: March 26, 2018
• Last Updated: September 20, 2021

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)