Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy
- Conditions
- CIDP - Chronic Inflammatory Demyelinating PolyneuropathyGuillain-Barré Syndrome (GBS)
- Registration Number
- NCT07121985
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
- Pregnancy
- Breastfeeding mothers
- Cardiopulmonary instability
- Tattoo in the examination area
- Subcutaneous fat tissue > 3 cm
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Single Wavelength PA signal Single time point Photoacoustic single wavelength signal between 700nm and 1100nm in the measured nerves.
PA hemoglobin signal Single time point Unmixed photoacoustic hemoglobin signal (oxygenated, deoxygenated and derived saturation) in the measured nerves
Doppler signal Single time point Ultrasound-based Doppler signal in the measured nerves
- Secondary Outcome Measures
Name Time Method Nerve diameter Single time point Ultrasound-based dimensional measurements of the respective nerve.
Clinical scores Single time point Assessment of clinical scores (MRC, NIS) for correlation with imaging data.
PA lipid signal Single time point Unmixed photoacoustic lipid signal in the measured nerves
PA water signal Single time point Unmixed photoacoustic water signal in the measured nerves
PA collagen signal Single time point Unmixed photoacoustic collagen signal in the measured nerves