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

• 1 other identifier: MIND_study
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

CIDP - Chronic Inflammatory Demyelinating Polyneuropathy; Guillain-Barré Syndrome (GBS)

Keywords

MSOT; PAI; Nerve Ultrasound

Outcome Measures

Primary Outcomes (3)

• Single Wavelength PA signal

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

  Single time point

• PA hemoglobin signal

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

  Single time point

• Doppler signal

  Ultrasound-based Doppler signal in the measured nerves

  Single time point

Secondary Outcomes (5)

• Nerve diameter

  Single time point

• Clinical scores

  Single time point

• PA lipid signal

  Single time point

• PA water signal

  Single time point

• PA collagen signal

  Single time point

Study Arms (3)

Healthy Volunteers

Healthy Volunteers

GBS patients

GBS patients

CIDP patients

CIDP patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Established diagnosis or suspected CIDP or GBS
• 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.)

You may not qualify if:

• Pregnancy
• Breastfeeding mothers
• Cardiopulmonary instability
• Tattoo in the examination area
• Subcutaneous fat tissue \> 3 cm

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Post-Infectious Disorders

Central Study Contacts

Felix Wachter, Dr. med.

CONTACT

+49 09131 85 33118; felix.wachter@uk-erlangen.de

Adrian Bühler, M.Sc.

CONTACT

+49 09131 85 33118; adrian.buehler@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Dr. Humanbiol.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 14, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): August 6, 2026
• Study Completion (Estimated): August 6, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08