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

NCT ID: NCT03908047

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2021-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy volunteers

magnetic resonance imaging

Intervention Type: OTHER

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

Interventions

magnetic resonance imaging

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens Wöllner, Dr.

Role: PRINCIPAL_INVESTIGATOR

Senior Consultant Neuro-Urology

Locations

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Countries

Switzerland

Other Identifiers

2019-01

Identifier Type: -

Identifier Source: org_study_id