Clinical trial NCT05139732: Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities
Official title: Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Neurological Symptom Disorder
Paralysis
Conversion Disorder with Weakness/Paralysis
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2021-12-01
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FND patients are recruited at the Swiss Paraplegic Centre and the Inselspital Bern. Inpatient and outpatient SCI subjects are recruited in the Swiss Paraplegic Centre .

Brief summary: In functional neurological disorder (FND), neurological symptoms are present, such as paralysis, weakness and disturbed sensation of limbs, although clinically no abnormalities can be found. It is a poorly understood disorder with uncertain diagnosis, treatment and prognosis. In this study, the subtype functional paralysis is investigated with advanced neuroimaging techniques that go beyond standard clinical examinations. In previous research on FND, healthy volunteers have generally been used as a control group. However, since people with functional paralysis have similar symptoms to people with spinal cord injuries (SCI), it is intended to compare the three groups to find similarities and differences. With the proposed methods, the goal is to gain a detailed understanding of FND regarding nerve cell metabolism, diffusion pathways and neuronal networks involved in cognitive processes such as motor inhibition (reaction or no reaction depending on situation). Neurophysiological data, clinical assessments and questionnaires are carried out in addition to Magnetic Resonance Imaging (MRI).

The aim is to enrol 75 participants in this study, i.e. 25 people with FND, 25 people with SCI and 25 healthy control subjects.

The overall goal of the study is to find markers for FND for use in future studies to improve diagnosis and individualise therapy recommendation for both people with SCI and people with FND. Therefore, this study is a relevant step to understand FND and to diagnose this specific disease using objective MRI based diagnostic tools.


Eligibility criteria: Inclusion Criteria:

* Age between 18-65

Exclusion Criteria:

* Contraindication for magnetic resonance examinations (e.g. cardiac pacemaker, pregnancy, etc.)
* history of mental or neurological illness (addiction, central nervous system tumour and severe craniocerebral trauma)
* unable to hold a pen due to paralysis

Primary outcomes:
measure: Nerve Cell Metabolism
timeFrame: day 1
measure: Brain Functional Connectivity
timeFrame: day 1
measure: Fiber tracts in three dimensional mapping
timeFrame: day 1
Secondary outcomes:
measure: Satisfaction with Life Scale questionnaire
timeFrame: day 1
measure: Hospital Anxiety and Depression Scale questionnaire
timeFrame: day 1
measure: Numerical Rating Scale (NRS) questionnaire
timeFrame: day 1
measure: Sensibility testing according to International Standards for Neurological Classification of SCI (ISNCSCI)
timeFrame: day 1
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Research
state: Lucerne
Study officials:
References: