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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Established diagnosis or suspected CIDP or GBS

Age: 18 years or older

Written informed consent provided by participant

Written informed consent provided by participant

Disqualifiers

Pregnancy

Breastfeeding mothers

Cardiopulmonary instability

Tattoo in the examination area

Trial population

Patients with Guillain-Barré Syndrome (GBS) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) are recruited from the Department of Neurology. All participants will have a confirmed diagnosis of GBS or CIDP based on established clinical and diagnostic criteria. Recruitment will occur during or following their routine clinical appointments. Eligible patients who provide informed consent will be invited to participate in the study assessments.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 3 trial groups
Group A: Healthy Volunteers
Group B: GBS patients
Group C: CIDP patients

Trial outcomes

Primary outcomes

1

Single Wavelength PA signal

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

Time frame
Single time point
2

PA hemoglobin signal

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

Time frame
Single time point
3

Doppler signal

Ultrasound-based Doppler signal in the measured nerves

Time frame
Single time point

Secondary outcomes

1

Nerve diameter

Ultrasound-based dimensional measurements of the respective nerve.

Time frame
Single time point
2

Clinical scores

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

Time frame
Single time point
3

PA lipid signal

Unmixed photoacoustic lipid signal in the measured nerves

Time frame
Single time point
4

PA water signal

Unmixed photoacoustic water signal in the measured nerves

Time frame
Single time point

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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