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Completed

NCT Number: NCT03908047

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Other

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

Primary outcomes

  1. change in functional network connectivity

    Time frame: baseline; 30 minutes during nerve stimulation

    change in brain network activity identified by independent component analysis

Other outcomes

  1. gender

    Time frame: baseline

    male or female

  2. age

    Time frame: baseline

    time since birth in years

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 9, 2019
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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