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NCT Number: NCT07121985

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Single Wavelength PA signal

    Time frame: Single time point

    Photoacoustic single wavelength signal between 700nm and 1100nm in the measured nerves.

  2. PA hemoglobin signal

    Time frame: Single time point

    Unmixed photoacoustic hemoglobin signal (oxygenated, deoxygenated and derived saturation) in the measured nerves

  3. Doppler signal

    Time frame: Single time point

    Ultrasound-based Doppler signal in the measured nerves

Secondary outcomes

  1. Nerve diameter

    Time frame: Single time point

    Ultrasound-based dimensional measurements of the respective nerve.

  2. Clinical scores

    Time frame: Single time point

    Assessment of clinical scores (MRC, NIS) for correlation with imaging data.

  3. PA lipid signal

    Time frame: Single time point

    Unmixed photoacoustic lipid signal in the measured nerves

  4. PA water signal

    Time frame: Single time point

    Unmixed photoacoustic water signal in the measured nerves

  5. PA collagen signal

    Time frame: Single time point

    Unmixed photoacoustic collagen signal in the measured nerves

Study contacts

Contact information is provided by the study sponsor or research team.

Adrian Bühler, M.Sc.

CONTACT

[email protected]

+49 09131 85 33118

Felix Wachter, Dr. med.

CONTACT

[email protected]

+49 09131 85 33118

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Acronym: MIND

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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