Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, Guillain-Barré Syndrome (GBS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Single Wavelength PA signal [Time frame: Single time point]
- PA hemoglobin signal [Time frame: Single time point]
- Doppler signal [Time frame: Single time point]
Secondary outcome measures (5)
- Nerve diameter [Time frame: Single time point]
- Clinical scores [Time frame: Single time point]
- PA lipid signal [Time frame: Single time point]
- PA water signal [Time frame: Single time point]
- PA collagen signal [Time frame: Single time point]
Eligibility criteria
Inclusion Criteria Patient Cohort(s):
- Established diagnosis or suspected CIDP or GBS
- Age: 18 years or older
- Written informed consent provided by participant
Inclusion Criteria Control Cohort:
- Written informed consent provided by participant
- Age: 18 years or older
- No pre-existing conditions that may affect peripheral nerves (e.g., diabetes, traumatic nerve injuries, etc.)
Exclusion criteria
- Pregnancy
- Breastfeeding mothers
- Cardiopulmonary instability
- Tattoo in the examination area
- Subcutaneous fat tissue > 3 cm
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07121985 · MIND_study