Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices

NCT07273903 | Recruiting

• 1 other identifier: STEPS_1.0
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

CIDP; IVIG; SCIG; wearable; steps; sleep; DHT

Outcome Measures

Primary Outcomes (4)

• 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

  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

  Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)

• Longitudinal development of activity parameter: step count

  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

  365 days

Secondary Outcomes (31)

• Change in Grip strength

  Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)

• Change in Medical Research Council (MRC)-Sumscore

  Baseline up to 12 months, 5 visits (months 0, 3, 6, 9, and 12)

• Longitudinal development of activity parameter: approximate distance traveled (meter)

  365 days

• Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings

  365 days

• Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings

  365 days

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Inability to operate smartwatch or smartphone device
• current pregnancy and breastfeeding status
• CIDP variants according to the 2021 EAN/PNS criteria

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (2)

University Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

University Hospital Münster

Münster, North Rhine-Westphalia, 48149, Germany

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 40635238 BACKGROUND

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

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

Study Officials

• Marc G Pawlitzki, PD Dr. med.

  Department of Neurology, Heinrich-Heine University, and University Hospital Duesseldorf, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc G Pawlitzki, PD Dr. med.

CONTACT

+49 02118117887; neuro-trials@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator / PI

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)