TrialReader


Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy

NCT07121985 — Not yet recruiting, 30 participants, University of Erlangen-Nürnberg Medical School

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT07121985, acronym MIND
StatusNot yet recruiting
Study typeObservational
Enrollment30 (Estimated)
SponsorUniversity of Erlangen-Nürnberg Medical School (Other)
ConditionsCIDP - Chronic Inflammatory Demyelinating Polyneuropathy, Guillain-Barré Syndrome (GBS)
Datesstart 2025-08-06 (estimated), primary completion 2026-08-06 (estimated), completion 2027-08-06 (estimated), first posted 2025-08-14, last updated 2025-08-14

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for CIDP - Chronic Inflammatory Demyelinating Polyneuropathy All trials for Guillain-Barré Syndrome (GBS)

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Healthy VolunteersHealthy Volunteers
GBS patientsGBS patients
CIDP patientsCIDP patients

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

My Notes