CIDP - Chronic Inflammatory Demyelinating PolyneuropathySTEPSNCT07273903
Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices
An observational study of CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
Trial summary
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune disease that affects the peripheral nerves. It causes progressive weakness and sensory loss in the arms and legs, which can severely limit daily activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
- How many people
- 35 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Jan 2026to Jan 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: CIDP adult patients (≥18 years) with typical or possible typical CIDP (2021 EAN/PNS criteria), switched from IVIG to fSCIG within 6 months or during recruitment
Who may be able to join
- Diagnosed typical or possible typical CIDP according to the 2021 EAN/PNS criteria
- Age ≥18 years
- Ability to use a smartwatch as decided by the investigator
- switched from IVIG to fSCIG within the prior 6 months or plan to switch during study recruitment phase
- on investigator-confirmed stable IVIG therapy pre-switch
Who cannot join
- Age < 18 years
- Inability to operate smartwatch or smartphone device
- current pregnancy and breastfeeding status
- CIDP variants according to the 2021 EAN/PNS criteria
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Marc G Pawlitzki, PD Dr. med., +49 02118117887, neuro-trials@med.uni-duesseldorf.de
- Recruiting
University Hospital Münster
Münster, North Rhine-Westphalia, 48149
Matthias Schilling, Prof. Dr. med., +49 251 83-48199, matthias.schilling@-ukmuenster.-de
About this study
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune disease that affects the peripheral nerves. It causes progressive weakness and sensory loss in the arms and legs, which can severely limit daily activities. Many patients need long-term treatment with immunoglobulins, either through intravenous infusions (IVIG) or subcutaneous injections (fSCIG).
The S.T.E.P.S. study aims to explore how digital health technologies-specifically smartwatches-can help monitor the disease course and treatment effects in CIDP patients who use fSCIG at home. Current clinical tests are useful but sometimes miss small changes in strength or function. Wearables may provide a more detailed and continuous picture of patients' health between clinic visits.
Read more
Study Goals:
The main goal is to find out whether smartwatch data (such as step count and physical activity) reflect disease severity and treatment response when compared to standard clinical scores like the Inflammatory Neuropathy Cause and Treatment (INCAT) scale and the Inflammatory Rasch-built Overall Disability Scale (I-RODS).
Secondary goals include:
Assessing how smartwatch data relate to patients' quality of life and sleep patterns.
Comparing smartwatch results with other clinical scores such as muscle strength (MRC sum score) and grip strength.
Evaluating how well patients can use the smartwatch over the long term during home treatment.
An additional exploratory goal is to see whether smartwatch data can detect early signs of worsening disease before symptoms appear.
Study Design:
This is a 12-month observational study with five main clinic visits (at 0, 3, 6, 9, and 12 months). After enrolling, participants will begin or continue subcutaneous immunoglobulin therapy as decided by their treating physician. Each visit includes standard clinical assessments and questionnaires.
Participants will receive a smartwatch at the start of the study to continuously track their activity and sleep patterns. A follow-up phone call one week later will check that the device is working properly.
Duration:
Recruitment will last about 6 months, and each participant will be followed for 12 months.
Why This Matters:
By combining established clinical measures with continuous digital monitoring, the S.T.E.P.S. study may help improve understanding of disease activity and treatment response in CIDP. This could lead to more personalized therapy schedules and better long-term care for patients.
- Keywords
- CIDP, IVIG, SCIG, wearable, steps, sleep, DHT
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
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 |
|---|---|---|
| CIDP patients | CIDP patients (≥18 years) with typical or possible typical CIDP (2021 EAN/PNS criteria), Switched from IVIG to fSCIG within 6 months or during recruitment, Must be able to use smartwatch + smartphone, Exclude: CIDP variants, pregnancy, breastfeeding, inability to use devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS)
24-item scale, with each item representing a common, daily activity minimum value: 0 points, maximum value: 48 points, best result: 48 points
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
minimum value: 0 points, maximum value: 10 points, best result: 0 points
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Longitudinal development of activity parameter: step count
Measured: 365 days
Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings
Examples for moderate activity:
Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton, Taking a bike ride, Gardening
Measured: 365 days
Secondary outcomes (31)
Change in Grip strength
Measured via Vigorimeter in kPa
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Medical Research Council (MRC)-Sumscore
minimum value: 0 points, maximum value: 60 points, best result: 60 points
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Longitudinal development of activity parameter: approximate distance traveled (meter)
Measured: 365 days
Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings
Examples for soft activity:
Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television, Doing the dishes
Measured: 365 days
Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings
Examples for intense activity:
Hiking, Running, Carrying heavy loads, Riding a bike, Playing football,baseball, or tennis (singles), Playing jump rope
Measured: 365 days
Longitudinal development of activity parameter: sum of all active time (seconds)
Measured: 365 days
Wearing time of smartwatch (daily)
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Longitudinal development of activity parameter: approximate calories burned
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Subjective occurrence of end-of-dose phenomena/wearing off
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Quality of life (QoL)
The Quality of Life Questionnaire (QoL) is an instrument for measuring patients' subjective quality of life in a wide range of specific areas, WHOQOL-BREF (World Health Organization Quality of Life - abbreviated version)
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Blood analysis (levels of sNfl, serum proteomics)
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Questionnaire about smartwatch usage
Measured: End of study visit (after 12 months, V5)
Longitudinal development of sleep parameter: time awake (seconds)
Measured: 365 days
Longitudinal development of sleep parameter: number of times user woke up
Measured: 365 days
Longitudinal development of sleep parameter: time to sleep (seconds)
Measured: 365 days
Longitudinal development of sleep parameter: total time in bed (seconds)
Measured: 365 days
Longitudinal development of sleep parameter: total time asleep (seconds)
Measured: 365 days
Longitudinal development of sleep parameter: WASO
Wake after sleep onset (WASO): total time asleep divided by total time in bed
Measured: 365 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
Measured: 365 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
Measured: 365 days
Longitudinal development of sleep parameter: Withings Sleep score
Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points based on 4 key inputs:
- Duration (total time spent sleeping)
- Depth (part of night spent in restorative phases and deep sleep)
- Regularity (consistency between your bed- and rise-times)
- Interruptions (time spent awake)
Measured: 365 days
Longitudinal development of cardiovascular parameter: average heartrate
Measured: 365 days
Longitudinal development of cardiovascular parameter: maximal heartrate
Measured: 365 days
Longitudinal development of cardiovascular parameter: minimum heartrate
Measured: 365
Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds)
Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.
Measured: 365 days
Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds)
Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.
Measured: 365 days
Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds)
Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.
Measured: 365 days
Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds)
Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate.
Measured: 365 days
Number and time of Irregular 1-channel ECGs (according to Withings algorithm)
Measured: 365 days
Change in Fatigue Severity Scale (FSS)
Measured: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start15 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CIDP - Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Marc Günter Pawlitzki, Heinrich-Heine University, Duesseldorf
- Investigators
- Marc G Pawlitzki, PD Dr. med., Principal investigator, Department of Neurology, Heinrich-Heine University, and University Hospital Duesseldorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273903
- Sponsor's protocol ID
- STEPS_1.0
- Acronym
- STEPS
- Status last verified
- Jun 2026
- First submitted
- 27 Nov 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masanneck L, Voth J, Gmahl N, Jendretzky K, Huntemann N, Werner NM, Schmidt L, Oeztuerk M, Quint P, Schroeter CB, Hartung HP, Skripuletz T, Meyer Zu Horste G, Ruck T, Meuth SG, Pawlitzki M. Digital Activity Markers in Chronic Inflammatory Demyelinating Polyneuropathy. Ann Clin Transl Neurol. 2025 Oct;12(10):2045-2055. doi: 10.1002/acn3.70137. Epub 2025 Jul 9.
PubMed 40635238
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices
- ClinicalTrials.gov ID
- NCT07273903
- Acronym / sponsor ID
- STEPS / STEPS_1.0
- Keywords
- CIDP, IVIG, SCIG, wearable, steps, sleep, DHT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Dec 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.
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune disease that affects the peripheral nerves. It causes progressive weakness and sensory loss in the arms and legs, which can severely limit daily activities. Many patients need long-term treatment with immunoglobulins, either through intravenous infusions (IVIG) or subcutaneous injections (fSCIG).
The S.T.E.P.S. study aims to explore how digital health technologies-specifically smartwatches-can help monitor the disease course and treatment effects in CIDP patients who use fSCIG at home. Current clinical tests are useful but sometimes miss small changes in strength or function. Wearables may provide a more detailed and continuous picture of patients' health between clinic visits.
Study Goals:
The main goal is to find out whether smartwatch data (such as step count and physical activity) reflect disease severity and treatment response when compared to standard clinical scores like the Inflammatory Neuropathy Cause and Treatment (INCAT) scale and the Inflammatory Rasch-built Overall Disability Scale (I-RODS).
Secondary goals include:
Assessing how smartwatch data relate to patients' quality of life and sleep patterns.
Comparing smartwatch results with other clinical scores such as muscle strength (MRC sum score) and grip strength.
Evaluating how well patients can use the smartwatch over the long term during home treatment.
An additional exploratory goal is to see whether smartwatch data can detect early signs of worsening disease before symptoms appear.
Study Design:
This is a 12-month observational study with five main clinic visits (at 0, 3, 6, 9, and 12 months). After enrolling, participants will begin or continue subcutaneous immunoglobulin therapy as decided by their treating physician. Each visit includes standard clinical assessments and questionnaires.
Participants will receive a smartwatch at the start of the study to continuously track their activity and sleep patterns. A follow-up phone call one week later will check that the device is working properly.
Duration:
Recruitment will last about 6 months, and each participant will be followed for 12 months.
Why This Matters:
By combining established clinical measures with continuous digital monitoring, the S.T.E.P.S. study may help improve understanding of disease activity and treatment response in CIDP. This could lead to more personalized therapy schedules and better long-term care for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIDP patients | – | –CIDP patients (≥18 years) with typical or possible typical CIDP (2021 EAN/PNS criteria), Switched from IVIG to fSCIG within 6 months or during recruitment, Must be able to use smartwatch + smartphone, Exclude: CIDP variants, pregnancy, breastfeeding, inability to use devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CIDP adult patients (≥18 years) with typical or possible typical CIDP (2021 EAN/PNS criteria), switched from IVIG to fSCIG within 6 months or during recruitment
Key inclusion criteria (5 listed)
- Diagnosed typical or possible typical CIDP according to the 2021 EAN/PNS criteria
- Age ≥18 years
- Ability to use a smartwatch as decided by the investigator
- switched from IVIG to fSCIG within the prior 6 months or plan to switch during study recruitment phase
- on investigator-confirmed stable IVIG therapy pre-switch
Key exclusion criteria (4 listed)
- Age < 18 years
- Inability to operate smartwatch or smartphone device
- current pregnancy and breastfeeding status
- CIDP variants according to the 2021 EAN/PNS criteria
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
Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS)
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
24-item scale, with each item representing a common, daily activity minimum value: 0 points, maximum value: 48 points, best result: 48 points
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
minimum value: 0 points, maximum value: 10 points, best result: 0 points
Longitudinal development of activity parameter: step count
Time frame: 365 days
Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings
Time frame: 365 days
Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton, Taking a bike ride, Gardening
31 secondary outcomes
Change in Grip strength
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Medical Research Council (MRC)-Sumscore
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Longitudinal development of activity parameter: approximate distance traveled (meter)
Time frame: 365 days
Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings
Time frame: 365 days
Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings
Time frame: 365 days
Longitudinal development of activity parameter: sum of all active time (seconds)
Time frame: 365 days
Wearing time of smartwatch (daily)
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Longitudinal development of activity parameter: approximate calories burned
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Subjective occurrence of end-of-dose phenomena/wearing off
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Quality of life (QoL)
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Change in Blood analysis (levels of sNfl, serum proteomics)
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
Questionnaire about smartwatch usage
Time frame: End of study visit (after 12 months, V5)
Longitudinal development of sleep parameter: time awake (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: number of times user woke up
Time frame: 365 days
Longitudinal development of sleep parameter: time to sleep (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: total time in bed (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: total time asleep (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: WASO
Time frame: 365 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
Time frame: 365 days
Longitudinal development of sleep parameter: Withings Sleep score
Time frame: 365 days
Longitudinal development of cardiovascular parameter: average heartrate
Time frame: 365 days
Longitudinal development of cardiovascular parameter: maximal heartrate
Time frame: 365 days
Longitudinal development of cardiovascular parameter: minimum heartrate
Time frame: 365
Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds)
Time frame: 365 days
Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds)
Time frame: 365 days
Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds)
Time frame: 365 days
Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds)
Time frame: 365 days
Number and time of Irregular 1-channel ECGs (according to Withings algorithm)
Time frame: 365 days
Change in Fatigue Severity Scale (FSS)
Time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)
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 10 Jun 2026.
- Background: PubMed 40635238Masanneck L, Voth J, Gmahl N, Jendretzky K, Huntemann N, Werner NM, Schmidt L, Oeztuerk M, Quint P, Schroeter CB, Hartung HP, Skripuletz T, Meyer Zu Horste G, Ruck T, Meuth SG, Pawlitzki M. Digital Activity Markers in Chronic Inflammatory Demyelinating Polyneuropathy. Ann Clin Transl Neurol. 2025 Oct;12(10):2045-2055. doi: 10.1002/acn3.70137. Epub 2025 Jul 9.
- Individual participant dataSharing planned: No
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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.
Marc G Pawlitzki, PD Dr. med. principal investigator
Department of Neurology, Heinrich-Heine University, and University Hospital Duesseldorf, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Marc G Pawlitzki, PD Dr. med. (+49 02118117887, neuro-trials@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) (time frame: Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07273903, which also lists 1 linked publication.
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 10 Jun 2026.