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NCT05723848
Electronic Monitoring of Disease Activity in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Conditions: CIDP
Sex: All
Ages: 18 Years – N/A
Enrollment: 60
Sponsor: Heinrich-Heine University, Duesseldorf
Location: Germany
Summary
This clinical, prospective study aims to evaluate the usefulness of electronically captured wearable data to assess disease activity in CIDP (chronic inflammatory demyelinating polyneuropathy) patients undergoing IVIG treatment.
Close clinical monitoring will complement smartwatch-acquired data to shed light on different patient clusters and end-of-dose phenomena.
Eligibility Criteria
Inclusion Criteria:IVIG treated ?
(all criteria a-c must be met):Documented evidence of objective response to IVIG, with clinically meaningful improvement.
Clinically meaningful improvement is defined as one of the following: ≥1-point decrease in adjusted INCAT score, ≥4 points increase in I-RODS total score, ≥3 points increase in MRC Sum score, ≥8 kilopascal improvement in mean grip strength (one hand), or an equivalent improvement based on information documented in medical records and per the PI's judgement.Must be on stable IVIG therapy, defined as no change greater than 10% in frequency or dose of immunoglobulin therapy or corticosteroids within 8 weeks prior to screeningEvidence of clinically meaningful deterioration on interruption or dose reduction of IVIG therapy within 24 months prior to screening, determined by clinical examination or medical records.
Clinically meaningful deterioration is defined as one of the following: ≥1-point increase in adjusted INCAT score, decrease in I-RODS total score ≥4 points, decrease in MRC Sum score ≥3, mean grip strength worsening of ≥8 kilopascals (one hand), or an equivalent deterioration based on information from medical records and at the PI's judgement.Exclusion Criteria:unable to use smartwatch or/and smartphone device
Source: ClinicalTrials.gov (NCT05723848). StuddyBuddy aggregates publicly available trial information.