Myasthenia GravisPOWER-MGNCT06441825
Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis
An observational study of Myasthenia Gravis and Myasthenic Syndrome, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
This observational study seeks to investigate the underlying processes of myasthenia gravis by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, we aim to enhance the detection of disease activity and establish correlations between digital measures, clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis, Myasthenic Syndrome, Lambert-Eaton Myasthenic Syndrome
- What is being tested?
- Increased multimodal observation including digital monitoring
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2024to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with myasthenic syndromes treated at the University Clinic Duesseldorf.
Who may be able to join
None listed.
Who cannot join
- Patients who meet any of the following criteria will be excluded from participation:
- Unable or unwilling to give informed consent
- Unable or unwilling to use the smartphone app
- Any significant comorbidity that might potentially interfere with the ability to successfully participate in the study, based on investigator´s judgment
- Patient with exclusively ocular symptoms (ocular myasthenia gravis)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heinrich-Heine University, Duesseldorf
Düsseldorf
Marc Günter Pawlitzki, PD Dr. med., +49211 8117887, neuro-trials@med.uni-duesseldorf.de
Lars Masanneck, Dr. med.
About this study
This observational study seeks to investigate the underlying processes of myasthenia gravis by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, we aim to enhance the detection of disease activity and establish correlations between digital measures, clinical scores and various questionnaires including sores on quality of life, sleep quality or activities of daily living. Primarily including patients treated with newly approved drugs, it aims at improving and monitoring the efficacy and safety of treatment and allowing a more individualized treatment.
Read the detailed description
Myasthenia Gravis (MG) is a chronic autoimmune disease characterized by muscle weakness and fatigue due to defective transmission at the neuromuscular junction. Typically, symptomatic assessments occur during clinical encounters, either as part of routine treatment assessments or in acute situations such as myasthenic crises. However, for a comprehensive understanding of mechanisms in MG and disease activity, continuous monitoring is essential.
Utilization of digital biomarkers derived from wearable devices offers unprecedented insights into diseases like MG and allows us to establish correlations between digital measures, clinical scores such as the QMG scale and MGC, as well as various questionnaires addressing sleep quality, quality of life or activities of daily living.
Data recorded by the used wearables (Withings Scanwatch 2) cover various parameters including 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.).
Prospectively, this study aims at improving patient care by gaining a deeper insight into Myasthenia Gravis and its dynamic disease activity while concurrently monitoring the efficacy and safety of treatments, particularly of the newly approved drugs for MG.
In the future, wearables might hold the potential to improve treatment processes and optimize therapeutic approaches. For instance, digital biomarkers could serve as early warning signs for phenomena like heightened disease activity or end-of-dose phenomena, paving the way for personalized treatment strategies tailored to individual patient needs.
- Being tested
- Increased multimodal observation including digital monitoring
- Medical subject headings
- Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased multimodal observation including digital monitoringOther
Also called Withings Scanwatch 2
Digital monitoring combined with repeated clinical assessments and retrospective analysis of serological markers
| Study group | Role | What they receive |
|---|---|---|
| Myasthenic Syndromes Observational Cohort | Cohort to be characterized via clinical, serological and digital observations Receives: Other: Increased multimodal observation including digital monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
QMG: Quantitative Myasthenia Gravis Scale
The QMG-Score is a clinical tool to assess the severity of symptoms in MG. It evaluates muscle strength and function in specific muscle groups (ocular, oral, facial, neck and limb muscles), grip strength and vital capacity. It ranges from 0 to 39, with higher scores indicating an increased symptom load.
Measured: 6 months, monthly
MGC: Myasthenia Gravis Composite
The MGC is a clinical tool to evaluate the severity and progression of MG. It ranges from 0 to 50, with higher scores indicating a higher severity of MG.
Measured: Baseline, after 3 and 6 months
MGFA-PIS: Myasthenia Gravis Post intervention status
The MGFA-PIS is a scoring system used to assess the status of patients with MG. It divides MG presentations into different classes, classifying outcome measures and treatment effectiveness. It has 8 classes; Minimal Manifestation can be further described within four dimensions.
Measured: Baseline, after 3 and 6 months
MG-ADL: Myasthenia Gravis Activities of Daily Living
The MG-ADL is a tool used to assess the functional status of patients with MG in their daily activities. It consists of questions related to various activities of daily living such as speaking, chewing, swallowing, walking etc. It ranges from 0 to 24, with higher scores indicating a greater impairment in daily life.
Measured: Baseline, after 3 and 6 months
MG-QoL15: Myasthenia Gravis Quality of Life-15
The MG-QoL assesses the quality of life in patients with MG, covering various aspects of daily life such as physical functioning, social interactions, emotional well-being and overall satisfaction with life.
It ranges from 0 to 60, with higher scores indicating a greater impact of MG on life quality.
Measured: Baseline, after 3 and 6 months
Secondary outcomes (30)
WHOQoL-BREF: World Health Organization Quality of Life Questionnaire Brief Version
The WHOQOL-BREF questionnaire measures quality of life across 4 domains: Physical health, psychological health, social relationships and environment. It also includes one question on overall QOL and one on general health. The WHOQOL-BREF scores correlate highly (.89 or above) with WHOQOL-100 scores, and demonstrate good discriminant validity, content validity, internal consistency and test-retest reliability. The four WHOQOL-BREF domain scores will be used as main outcome measure. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval, with higher scores corresponding to greater QOL.
Measured: Baseline, after 3 and 6 months
HADSD: Hospital Anxiety and Depression Scale
The HADSD is a self-assessment questionnaire measuring levels of anxiety and depression in patients. It contains two subscales: one for anxiety and one for depression. Total scores range from 0 to 42, with higher scores indicatiBAng higher levels of anxiety or depression.
Measured: Baseline, after 3 and 6 months
EoD-Questionnaire: End of Dose-Questionnaire
The EoD-Questionnaire assesses the effectiveness of a treatment at the end of its dosing interval and asks about an increase in symptoms.
Measured: Baseline, after 3 and 6 months
Sleep-Questionnaire:
The Sleep-Questionnaire contain the Pittsburgh Sleep Quality Index (PSQI) as well as two Items on the perceived impact of the smartwatch on the patient´s sleep. The PSQI assesses the quality of sleep over a one-month interval and measures seven component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Total score ranges from 0 to 21, with higher scores indicating a poorer sleep quality.
Measured: Baseline, after 3 and 6 months
10. Questionnaire on Smartwatch Usage (after 6 Months) containing the System Usability Scale
Measured: After 6 months
Digital Measurements: Activity parameters - Longitudinal development of step count
Measured: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of approximate distance travelled (meter)
Measured: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of duration of soft activity (seconds) as defined by Withings
Measured: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of duration of moderate activity (seconds) as defined by Withings
Measured: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of duration of itnense activity (seconds) as defined by Withings
Measured: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of active time (seconds) as defined by Withings
Measured: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of approximate calories burned as defined by Withings
Measured: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of time awake (seconds)
Measured: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of number of times user woke up
Measured: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of time to sleep (seconds)
Measured: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of total time asleep (seconds)
Measured: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of total time in bed (seconds)
Measured: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of ratio of sleep/time in bed
Measured: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of time spent in bed before falling asleep (seconds)
Measured: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of time awake after first falling asleep (seconds)
Measured: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of Withings sleep Score as defined by Withings
Measured: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of average heartrate (beats/min)
Measured: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of maximal heartrate (beats/min)
Measured: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of minimum heartrate (beats/min)
Measured: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of time in light heartrate zone (seconds)
Measured: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of time in moderate heartrate zone (seconds)
Measured: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of time in intense heartrate zone (seconds)
Measured: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of time in maximal heartrate zone (seconds)
Measured: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of heart rate variability (milliseconds)
Measured: 6 months, continuously
Smartwatch adherence
Wearing time of smartwatch (daily)
Measured: Continously 6 motnhs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start2 May 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies 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
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441825
- Sponsor's protocol ID
- MPGv1.0
- Acronym
- POWER-MG
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT06441825
- Acronym / sponsor ID
- POWER-MG / MPGv1.0
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 4 Jun 2024 (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.
This observational study seeks to investigate the underlying processes of myasthenia gravis by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, we aim to enhance the detection of disease activity and establish correlations between digital measures, clinical scores and various questionnaires including sores on quality of life, sleep quality or activities of daily living. Primarily including patients treated with newly approved drugs, it aims at improving and monitoring the efficacy and safety of treatment and allowing a more individualized treatment.
Detailed description
Myasthenia Gravis (MG) is a chronic autoimmune disease characterized by muscle weakness and fatigue due to defective transmission at the neuromuscular junction. Typically, symptomatic assessments occur during clinical encounters, either as part of routine treatment assessments or in acute situations such as myasthenic crises. However, for a comprehensive understanding of mechanisms in MG and disease activity, continuous monitoring is essential.
Utilization of digital biomarkers derived from wearable devices offers unprecedented insights into diseases like MG and allows us to establish correlations between digital measures, clinical scores such as the QMG scale and MGC, as well as various questionnaires addressing sleep quality, quality of life or activities of daily living.
Data recorded by the used wearables (Withings Scanwatch 2) cover various parameters including 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.).
Prospectively, this study aims at improving patient care by gaining a deeper insight into Myasthenia Gravis and its dynamic disease activity while concurrently monitoring the efficacy and safety of treatments, particularly of the newly approved drugs for MG.
In the future, wearables might hold the potential to improve treatment processes and optimize therapeutic approaches. For instance, digital biomarkers could serve as early warning signs for phenomena like heightened disease activity or end-of-dose phenomena, paving the way for personalized treatment strategies tailored to individual patient needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myasthenic Syndromes Observational Cohort | – | Other: Increased multimodal observation including digital monitoringCohort to be characterized via clinical, serological and digital observations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myasthenic syndromes treated at the University Clinic Duesseldorf.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Unable or unwilling to give informed consent
- Unable or unwilling to use the smartphone app
- Any significant comorbidity that might potentially interfere with the ability to successfully participate in the study, based on investigator´s judgment
- Patient with exclusively ocular symptoms (ocular myasthenia gravis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased multimodal observation including digital monitoringAlso: Withings Scanwatch 2Digital monitoring combined with repeated clinical assessments and retrospective analysis of serological markers | Other | Myasthenic Syndromes Observational Cohort |
Primary outcome
QMG: Quantitative Myasthenia Gravis Scale
Time frame: 6 months, monthly
The QMG-Score is a clinical tool to assess the severity of symptoms in MG. It evaluates muscle strength and function in specific muscle groups (ocular, oral, facial, neck and limb muscles), grip strength and vital capacity. It ranges from 0 to 39, with higher scores indicating an increased symptom load.
MGC: Myasthenia Gravis Composite
Time frame: Baseline, after 3 and 6 months
The MGC is a clinical tool to evaluate the severity and progression of MG. It ranges from 0 to 50, with higher scores indicating a higher severity of MG.
MGFA-PIS: Myasthenia Gravis Post intervention status
Time frame: Baseline, after 3 and 6 months
The MGFA-PIS is a scoring system used to assess the status of patients with MG. It divides MG presentations into different classes, classifying outcome measures and treatment effectiveness. It has 8 classes; Minimal Manifestation can be further described within four dimensions.
MG-ADL: Myasthenia Gravis Activities of Daily Living
Time frame: Baseline, after 3 and 6 months
The MG-ADL is a tool used to assess the functional status of patients with MG in their daily activities. It consists of questions related to various activities of daily living such as speaking, chewing, swallowing, walking etc. It ranges from 0 to 24, with higher scores indicating a greater impairment in daily life.
MG-QoL15: Myasthenia Gravis Quality of Life-15
Time frame: Baseline, after 3 and 6 months
The MG-QoL assesses the quality of life in patients with MG, covering various aspects of daily life such as physical functioning, social interactions, emotional well-being and overall satisfaction with life. It ranges from 0 to 60, with higher scores indicating a greater impact of MG on life quality.
30 secondary outcomes
WHOQoL-BREF: World Health Organization Quality of Life Questionnaire Brief Version
Time frame: Baseline, after 3 and 6 months
HADSD: Hospital Anxiety and Depression Scale
Time frame: Baseline, after 3 and 6 months
EoD-Questionnaire: End of Dose-Questionnaire
Time frame: Baseline, after 3 and 6 months
Sleep-Questionnaire:
Time frame: Baseline, after 3 and 6 months
10. Questionnaire on Smartwatch Usage (after 6 Months) containing the System Usability Scale
Time frame: After 6 months
Digital Measurements: Activity parameters - Longitudinal development of step count
Time frame: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of approximate distance travelled (meter)
Time frame: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of duration of soft activity (seconds) as defined by Withings
Time frame: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of duration of moderate activity (seconds) as defined by Withings
Time frame: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of duration of itnense activity (seconds) as defined by Withings
Time frame: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of active time (seconds) as defined by Withings
Time frame: 6 months, continuously
Digital Measurements: Activity parameters - longitudinal development of approximate calories burned as defined by Withings
Time frame: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of time awake (seconds)
Time frame: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of number of times user woke up
Time frame: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of time to sleep (seconds)
Time frame: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of total time asleep (seconds)
Time frame: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of total time in bed (seconds)
Time frame: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of ratio of sleep/time in bed
Time frame: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of time spent in bed before falling asleep (seconds)
Time frame: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of time awake after first falling asleep (seconds)
Time frame: 6 months, continuously
Digital Measurements: Sleep parameters - longitudinal development of Withings sleep Score as defined by Withings
Time frame: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of average heartrate (beats/min)
Time frame: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of maximal heartrate (beats/min)
Time frame: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of minimum heartrate (beats/min)
Time frame: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of time in light heartrate zone (seconds)
Time frame: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of time in moderate heartrate zone (seconds)
Time frame: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of time in intense heartrate zone (seconds)
Time frame: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of time in maximal heartrate zone (seconds)
Time frame: 6 months, continuously
Digital Measurements: Cardiovascular parameters - longitudinal development of heart rate variability (milliseconds)
Time frame: 6 months, continuously
Smartwatch adherence
Time frame: Continously 6 motnhs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis and Myasthenic Syndrome, run by Heinrich-Heine University, Duesseldorf at 1 site 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 0 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Pawlitzki, PD Dr. med. (+49211 8117887, 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?
QMG: Quantitative Myasthenia Gravis Scale (time frame: 6 months, monthly). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2024.