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

Spinal Cord Injuries Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908047
• Other study ID #: 2019-01
• Status: Completed
• Start date: July 15, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 28, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder, Neurogenic
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic

Intervention

Other:
• magnetic resonance imaging
functional magnetic resonance imaging and diffusion tensor imaging after tibialis nerve stimulation

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	gender	male or female	baseline
Other	age	time since birth in years	baseline
Primary	change in functional network connectivity	change in brain network activity identified by independent component analysis	baseline; 30 minutes during nerve stimulation