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NCT03908047

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

Completed Last updated 2 December 2024
What this trial tests

trial testing magnetic resonance imaging in Spinal Cord Injuries in 15 participants. Completed in 28 February 2021.

Timeline
15 July 2019
Primary endpoint
31 December 2020
28 February 2021

Quick facts

Lead sponsorSwiss Paraplegic Research, Nottwil
StatusCompleted
Study typeOBSERVATIONAL
Enrollment15
Start date15 July 2019
Primary completion31 December 2020
Estimated completion28 February 2021
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Swiss Paraplegic Research, Nottwil — full company profile →

Who can join

Adults 18 to 50, any sex, with Spinal Cord Injuries or Bladder, Neurogenic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of magnetic resonance imaging

Trials testing the same drug.

Other recruiting trials for Spinal Cord Injuries

Currently open trials in the same condition.

Other Swiss Paraplegic Research, Nottwil trials

Trials by the same sponsor.

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Data sources for this page

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