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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-06

Study Completion Date

2027-08-06

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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.)

Exclusion Criteria

* Pregnancy
* Breastfeeding mothers
* Cardiopulmonary instability
* Tattoo in the examination area
* Subcutaneous fat tissue \> 3 cm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Ferdinand Knieling

PD Dr. med. Dr. Humanbiol.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Felix Wachter, Dr. med.

Role: CONTACT

+49 09131 85 33118

Adrian Bühler, M.Sc.

Role: CONTACT

+49 09131 85 33118

Other Identifiers

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MIND_study

Identifier Type: -

Identifier Source: org_study_id

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