Neuromodulation Therapy for Fecal Incontinence

Summary

Fecal Incontinence (FI) affects 8-15 % of the US population, predominantly women and elderly, and 45% of nursing home residents. It significantly impairs quality of life and poses a major health care burden. FI is characterized by significant neuromuscular dysfunction of the pelvic floor that includes bilateral lumbo-anorectal and sacro-anorectal neuropathy and sensori-motor dysfunction. This multifactorial etiology suggests that maladaptive neuroplastic changes in the neural innervation of lower gastrointestinal tract could play a significant role in the pathogenesis of FI. A critical barrier to progress in the treatment of FI is the lack of understanding of how treatments affect the core pathophysiological mechanisms of FI, and the absence of mechanistically based non-invasive therapies. Our goal is to address the problem of FI by developing therapies that modulate peripheral and central neuronal perturbations and thereby improve visceromotor control and sensori-motor dysfunctions, and to understand the neurobiologic basis of these treatments. Our central hypothesis is that a novel non-invasive treatment consisting of repetitive translumbar magnetic stimulation (rTLMS) and repetitive transsacral magnetic stimulation (rTSMS) will significantly improve FI by enhancing peripheral and central neural excitability and will provide a multidimensional therapeutic benefit- enhance anal muscle strength, improve stool perception and improve rectal capacity. Our approach is based on our preliminary studies which suggest that repetitive translumbar magnetic stimulation (rTLMS) and transsacral magnetic stimulation (rTSMS) improve anorectal pain and neuropathy and induce central neuroplastic changes.

Our objectives are to:

1. address the significant gap in our knowledge regarding the peripheral and central neuroenteric axis and how perturbations in the afferent and efferent neural signaling can affect FI;
2. develop a new treatment for FI with repetitive magnetic stimulation and determine the feasibility, safety and optimal frequency setting of rTLMS and rTSMS;
3. determine the mechanistic basis for this neuromodulation therapy;
4. identify if the locus for improvement lies in the afferent or efferent signaling or both.

Conditions

• Fecal Incontinence

Interventions

PROCEDURE

Repetitive lumbosacral magnetic stimulation (rTLSMS)

Patients randomized to Six sessions of weekly therapy with either 1 HZ or 5 Hz or 15 Hz magnetic stimulations of the lumbar and sacral regions.

Sponsors & Collaborators

• University of Manchester

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Augusta University

  lead OTHER

Principal Investigators

• Satish Rao, MD, PhD · Augusta University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2018-03-31

Completion

2018-12-31

Countries

• United States
• United Kingdom

Study Locations