| Registry | NCT07121985, acronym MIND |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 30 (Estimated) |
| Sponsor | University of Erlangen-Nürnberg Medical School (Other) |
| Conditions | CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, Guillain-Barré Syndrome (GBS) |
| Dates | start 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 |
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All trials for CIDP - Chronic Inflammatory Demyelinating Polyneuropathy All trials for Guillain-Barré Syndrome (GBS)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Healthy Volunteers | Healthy Volunteers | ||
| GBS patients | GBS patients | ||
| CIDP patients | CIDP patients |
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