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NCT03908047
Functional Changes in the Brain After Tibial Nerve Stimulation: a Pilot Study
trial testing magnetic resonance imaging in Spinal Cord Injuries in 15 participants. Completed in 28 February 2021.
31 December 2020
Quick facts
| Lead sponsor | Swiss Paraplegic Research, Nottwil |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 15 |
| Start date | 15 July 2019 |
| Primary completion | 31 December 2020 |
| Estimated completion | 28 February 2021 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- magnetic resonance imaging
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
- Bladder, Neurogenic — all drugs for Bladder, Neurogenic →
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:
- PubMed search for NCT03908047
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03908047 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Swiss Paraplegic Research, Nottwil
- Last refreshed: 2 December 2024
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