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

Feasibility of Detecting Functional Changes in the Brain After Tibial Nerve Stimulation and the Association with the Sacral Roots Architecture: a Pilot Magnetic Resonance Study

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Bladder, Neurogenic
• Intervention / Treatment: Other: magnetic resonance imaging

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Switzerland
  • LU
    • Nottwil, LU, Switzerland, 6207
      • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

healthy volunteers

Description

Inclusion Criteria:

• healthy volunteers
• 18-50 years old
• informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers	Other: magnetic resonance imaging; functional magnetic resonance imaging and diffusion tensor imaging after tibialis nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in functional network connectivity	change in brain network activity identified by independent component analysis	baseline; 30 minutes during nerve stimulation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
gender	male or female	baseline
age	time since birth in years	baseline

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil
• Investigators: Principal Investigator: Jens Wöllner, Dr., Senior Consultant Neuro-Urology

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Trauma, Nervous System; Urinary Bladder Diseases; Spinal Cord Diseases; Spinal Cord Injuries; Urinary Bladder, Neurogenic
• Other Study ID Numbers: 2019-01 (Other Identifier: NANT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No