Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy
NCT ID: NCT07121985
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
30 participants
OBSERVATIONAL
2025-08-06
2027-08-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Volunteers
Healthy Volunteers
No interventions assigned to this group
GBS patients
GBS patients
No interventions assigned to this group
CIDP patients
CIDP patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age: 18 years or older
* Written informed consent provided by participant
* 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
* Breastfeeding mothers
* Cardiopulmonary instability
* Tattoo in the examination area
* Subcutaneous fat tissue \> 3 cm
18 Years
ALL
Yes
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Ferdinand Knieling
PD Dr. med. Dr. Humanbiol.
Central Contacts
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Other Identifiers
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MIND_study
Identifier Type: -
Identifier Source: org_study_id
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