About this trial
The aim of this study is to assess disease activity in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Guillain-Barré Syndrome (GBS) using multispectral optoacoustic tomography (MSOT).
The currently available diagnostic procedures for CIDP and GBS do not allow for a clear distinction between remission and active disease and show limitations in sensitivity and specificity during acute diagnostics. This can lead to delayed diagnosis, which is crucial for timely initiation of therapy and, consequently, for a better prognosis. Long-term therapy management is also challenging, as objective parameters for assessing therapeutic success are largely lacking.
MSOT can detect inflammation through the measurement of hemoglobin, a method that our research group has already successfully demonstrated in patients with chronic inflammatory bowel diseases (Knieling, NEJM 2017). The use of MSOT could therefore also be applied to nerve inflammation, allowing for earlier detection of inflammation and nerve damage and contributing to timely treatment of patients.
For nerve imaging, a CE-certified MSOT device from iThera Medical is available at the Pediatric Clinic in Erlangen. In addition, a non-CE-certified device with lower laser power is available, which can be used for bedside examinations.
The arm nerves will be examined in three cohorts, which will be compared with each other and with standard diagnostics (blood tests, electrophysiology, conventional ultrasound).
Each cohort will include ten healthy control subjects, ten patients with CIDP, and ten patients with GBS.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Established diagnosis or suspected CIDP or GBS
Age: 18 years or older
Written informed consent provided by participant
Written informed consent provided by participant
Disqualifiers
Pregnancy
Breastfeeding mothers
Cardiopulmonary instability
Tattoo in the examination area
Trial population
Patients with Guillain-Barré Syndrome (GBS) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) are recruited from the Department of Neurology. All participants will have a confirmed diagnosis of GBS or CIDP based on established clinical and diagnostic criteria. Recruitment will occur during or following their routine clinical appointments. Eligible patients who provide informed consent will be invited to participate in the study assessments.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Single Wavelength PA signal
Photoacoustic single wavelength signal between 700nm and 1100nm in the measured nerves.
PA hemoglobin signal
Unmixed photoacoustic hemoglobin signal (oxygenated, deoxygenated and derived saturation) in the measured nerves
Doppler signal
Ultrasound-based Doppler signal in the measured nerves
Secondary outcomes
Nerve diameter
Ultrasound-based dimensional measurements of the respective nerve.
Clinical scores
Assessment of clinical scores (MRC, NIS) for correlation with imaging data.
PA lipid signal
Unmixed photoacoustic lipid signal in the measured nerves
PA water signal
Unmixed photoacoustic water signal in the measured nerves
Locations
Sponsors and contacts
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