Clinical trial NCT05723848: Electronic Monitoring of Disease Activity in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Official title: A Prospective Study to Evaluate the Usefulness of Electronically Captured Wearable Data to Assess Disease Activity in CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) Patients Undergoing IVIG (Intravenous Immunoglobulin) Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CIDP
Keywords: Smartwatch
end of dose phenomenon
neuropathy
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CIDP patients with ongoing standard of care IVIG treatment, older or 18 years

Brief 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.

Detailed description: CIDP is a rare chronic neurological condition that leads to a considerable patient burden. As symptoms are often challenging to monitor, finding an individually optimal treatment regimen can be challenging. Additionally, patients receiving treatment often describe individual end-of-dose-phenomena, frequently leading to uncertainty regarding treatment intervals. Digital smartwatch-based measurements could add high-frequency real-world data to the picture and thus improve the understanding of individual disease courses.

Consequently, this study aims to evaluate different digital measurements and blood-based analyses to monitor disease activity in CIDP patients treated with intravenous immunoglobulins. Firstly, digital and blood-based measures will be compared to subjective patient reports and established clinical scores. Secondly, explorative analyses will aim to understand the longitudinal disease course and fluctuations thereof.

Data captured by the used smartwatches (Withings Scanwatch) includes activity-related data (step count, minutes in certain intensity levels), basic cardiovascular measurements such as heart rate, and sleep-related data (total time asleep, sleep quality, etc.). Blood-based measurements include serum neurofilament-light-chain (sNfL), glial fibrillary acidic protein (GFAP) and proteomic data. The investigators aim is to show can show whether therapy-dependent activity patterns, such as the end-of-dose phenomenon, are reflected in the recorded data.

Optionally, the digital signatures of CIDP patients will be compared to these of healthy controls wearing the smartwatch.

Patients were recruited in Düsseldorf and Münster.

Eligibility criteria: Inclusion Criteria:

* IVIG treated ? (all criteria a-c must be met):

  1. 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.
  2. 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 screening
  3. Evidence 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

Primary outcomes:
measure: Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS)
timeFrame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
timeFrame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Grip strength
timeFrame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Medical Research Council (MRC)-Sumscore
timeFrame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Subjective occurrence of end-of-dose phenomena/wearing off
timeFrame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Quality of life (QoL)
timeFrame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Blood analysis (levels of sNfl, serum proteomics)
timeFrame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Questionnaire about smartwatch usage
timeFrame: After 6 months (V3)
measure: Wearing time of smartwatch (daily)
timeFrame: 180 days
measure: Longitudinal development of activity parameter: step count
timeFrame: 180 days
measure: Longitudinal development of activity parameter: approximate distance traveled (meter)
timeFrame: 180 days
measure: Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings
timeFrame: 180 days
measure: Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings
timeFrame: 180 days
measure: Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings
timeFrame: 180 days
measure: Longitudinal development of activity parameter: sum of all active time (seconds)
timeFrame: 180 days
measure: Longitudinal development of activity parameter: approximate calories burned
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time awake (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: number of times user woke up
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time to sleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: total time in bed (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: total time asleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: ratio of sleep/time in bed
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: Withings Sleep score
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: average heartrate
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: maximal heartrate
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: minimum heartrate
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds)
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds)
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds)
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds)
timeFrame: 180 days
measure: Number and time of Irregular 1-channel ECGs (according to Withings algorithm)
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Medical Faculty, Heinrich-Heine-University
state: Northrhine-Westphalia
city: Münster
country: Germany
facility: University Hospital Münster, Department of Neurology
state: Northrhine-Westphalia
Study officials:
References: