CIDP - Chronic Inflammatory Demyelinating PolyneuropathyMINDNCT07121985
Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy
An observational study of CIDP - Chronic Inflammatory Demyelinating Polyneuropathy and Guillain-Barré Syndrome (GBS), run by University of Erlangen-Nürnberg Medical School.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, Guillain-Barré Syndrome (GBS)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2025to 6 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.)
Who cannot join
- Pregnancy
- Breastfeeding mothers
- Cardiopulmonary instability
- Tattoo in the examination area
- Subcutaneous fat tissue > 3 cm
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Keywords
- MSOT, PAI, Nerve Ultrasound
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers | |
| GBS patients | GBS patients | |
| CIDP patients | CIDP patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Wavelength PA signal
Photoacoustic single wavelength signal between 700nm and 1100nm in the measured nerves.
Measured: Single time point
PA hemoglobin signal
Unmixed photoacoustic hemoglobin signal (oxygenated, deoxygenated and derived saturation) in the measured nerves
Measured: Single time point
Doppler signal
Ultrasound-based Doppler signal in the measured nerves
Measured: Single time point
Secondary outcomes (5)
Nerve diameter
Ultrasound-based dimensional measurements of the respective nerve.
Measured: Single time point
Clinical scores
Assessment of clinical scores (MRC, NIS) for correlation with imaging data.
Measured: Single time point
PA lipid signal
Unmixed photoacoustic lipid signal in the measured nerves
Measured: Single time point
PA water signal
Unmixed photoacoustic water signal in the measured nerves
Measured: Single time point
PA collagen signal
Unmixed photoacoustic collagen signal in the measured nerves
Measured: Single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start6 Aug 2025 (estimated)
- Primary completion6 Aug 2026 (estimated)
- Study completion6 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIDP - Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferdinand Knieling, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121985
- Sponsor's protocol ID
- MIND_study
- Acronym
- MIND
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy
- ClinicalTrials.gov ID
- NCT07121985
- Acronym / sponsor ID
- MIND / MIND_study
- Keywords
- MSOT, PAI, Nerve Ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 6 Aug 2025 (estimated)
- Primary completion
- 6 Aug 2026 (estimated)
- Study completion
- 6 Aug 2027 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy Volunteers |
| GBS patients | – | –GBS patients |
| CIDP patients | – | –CIDP patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy
- Breastfeeding mothers
- Cardiopulmonary instability
- Tattoo in the examination area
- Subcutaneous fat tissue > 3 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Single Wavelength PA signal
Time frame: Single time point
Photoacoustic single wavelength signal between 700nm and 1100nm in the measured nerves.
PA hemoglobin signal
Time frame: Single time point
Unmixed photoacoustic hemoglobin signal (oxygenated, deoxygenated and derived saturation) in the measured nerves
Doppler signal
Time frame: Single time point
Ultrasound-based Doppler signal in the measured nerves
5 secondary outcomes
Nerve diameter
Time frame: Single time point
Clinical scores
Time frame: Single time point
PA lipid signal
Time frame: Single time point
PA water signal
Time frame: Single time point
PA collagen signal
Time frame: Single time point
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of CIDP - Chronic Inflammatory Demyelinating Polyneuropathy and Guillain-Barré Syndrome (GBS), run by University of Erlangen-Nürnberg Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Wachter, Dr. med. (+49 09131 85 33118, felix.wachter@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Wavelength PA signal (time frame: Single time point). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.