Functional Changes in the Brain After Tibial Nerve Stimulation: a Pilot Study

NCT03908047 | Completed

• 1 other identifier: 2019-01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The lower urinary tract is innervated by the autonomous (sympathetic, parasympathetic) and the somatic nervous system. Afferent information from the lower urinary tract (LUT) (e.g. filling state and volume of the urinary bladder) is conducted via the dorsal roots to the sacral spinal cord and from there to the pontine micturition center (PMC) in the brain stem. The PMC has several connections to other cortical areas. These complex interactions with the cortex enable voluntary control of the LUT and are crucial for urinary continence. The integrity of this neuronal circuit is crucial for an undisturbed function. Deterioration of the nerve fibers due to a systemic neurological disease (e.g. spinal cord injury) can affect LUT function. Neurogenic lower urinary tract dysfunction can lead to urgency, urge incontinence, reduced bladder capacity and secondary deterioration of the upper urinary tract (i.e. kidneys). First-line therapy of neurogenic detrusor overactivity contains antimuscarinic treatment. In case of side effects or remaining detrusor overactivity, nerve stimulation (e.g. sacral neuromodulation and in effect nerve tibialis stimulation) is an accepted therapy option. The precise mechanism of action of these neuro-modulatory procedures is still unknown. Utilizing state-of-the-art neuroimaging techniques, we intend to investigate the functional activation pattern after afferent tibialis nerve stimulation as well as the association with the architecture of the sacral roots. We aime to get a better insight into functional neuromodulation and central nervous processing. The study aim is to evaluate the feasibility in healthy subjects as a pilot study for the application of these method in patients with chronic, incomplete spinal cord injury.

Conditions

Spinal Cord Injuries; Bladder, Neurogenic

Outcome Measures

Primary Outcomes (1)

• change in functional network connectivity

  change in brain network activity identified by independent component analysis

  baseline; 30 minutes during nerve stimulation

Other Outcomes (2)

• gender

  baseline

• age

  baseline

Study Arms (1)

healthy volunteers

Other: magnetic resonance imaging

Interventions

magnetic resonance imaging OTHER

functional magnetic resonance imaging and diffusion tensor imaging after tibialis nerve stimulation

healthy volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

healthy volunteers

You may qualify if:

• healthy volunteers
• years old
• informed consent

You may not qualify if:

• history of neurological disease (eg. multiple sclerosis, epilepsy)
• cardiac pacemaker, insulin or other pumps
• claustrophobia
• pathological findings in the uroflowmetry or post void residual assessment
• medication with central nervous effects
• pregnancy or lactating
• unable to give informed consent

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jens Wöllner, Dr.

  Senior Consultant Neuro-Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: July 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 28, 2021
• Last Updated: December 2, 2024

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)