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Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices

NCT07273903 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2026-03-11

No results posted yet for this study

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

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Marc G Pawlitzki, PD Dr. med. · Department of Neurology, Heinrich-Heine University, and University Hospital Duesseldorf, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07273903 on ClinicalTrials.gov