Multiple SclerosisSMASHNCT06937723
Smart Monitoring Assessing Spasticity-related Health
An observational study of Multiple Sclerosis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
This observational study seeks to investigate the underlying of spasticity in patients with multiple sclerosis (MS) by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, the investigators aim to evaluate whether digital measurements are suitable for monitoring… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Device: Smartwatch (Withings Scanwatch)
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 19 Oct 2023to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 MS and 18 years or older
Who may be able to join
- Patients must meet all the following criteria to be eligible to participate in the study:
- ≥ 18 years of age
- Diagnosis of multiple sclerosis according to the McDonald criteria of 2017
- Presence of spasticity that requires medical treatment from a medical point of view
- own and use a smartphone with Android 8.1 (or higher version) or iOS 12.3 (or higher version)
- Able to operate a smartphone
Who cannot join
- Missing informed consent
- Lack of declaration of consent
- Unwillingness or inability to use the smartphone app
- Any comorbidity that leads to impaired understanding or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. The decision will be made at the discretion of the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Medical Faculty, Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225
Marc Pawlitzki, PD Dr. med., 0049 21181-17889, neuro-trials@med.uni-duesseldorf.de
About this study
Official title: Smart Monitoring Assessing Spasticity-related Health - A Prospective Multiple Sclerosis Study With Wearables
This observational study seeks to investigate the underlying of spasticity in patients with multiple sclerosis (MS) by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, the investigators aim to evaluate whether digital measurements are suitable for monitoring spasticity-related everyday limitations and to compare them with established clinical scores, blood analyses and questionnaires including sores on quality of life, sleep quality or activities of daily living.
Read the detailed description
The symptomatic treatment of spasticity in patients with multiple sclerosis (MS) is a major challenge for both patients and healthcare providers. However, monitoring and measuring the success or failure of treatments in clinical practice remains difficult. This is mainly due to the lack of clinical scores and biomarkers that can be easily and longitudinally collected. Existing scores (such as questionnaires and the Modified Ashworth scale) are rarely used in practice. In addition, the monitoring of side effects (such as dizziness, nausea and fatigue) is difficult in routine clinical practice and often leads to premature discontinuation or switching of treatment. As a result, therapeutic options are often exhausted prematurely. Continuous monitoring with sensitive assessments could enable a better understanding of spasticity treatment.
Approximately 50 patients with moderate and severe spasticity due to MS are to be included in the study. After inclusion, follow-up examinations are carried out every 12 weeks; a total of 3 visits are planned, including the baseline examination.
The study aims to improve the understanding of spasticity symptoms and assess them in patients through multimodal clinical and longitudinal digital measurements.
- Conditions
- Multiple Sclerosis
- Being tested
- Device: Smartwatch (Withings Scanwatch)
- Keywords
- Multiple Sclerosis, Spasticity, Smartwatch, Wearables, Digital health tools
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Smartwatch (Withings Scanwatch)Other
All-day monitoring of patients via smartwatch
| Study group | Role | What they receive |
|---|---|---|
| MS patients | Patients with Multiple Sclerosis Receives: Other: Device: Smartwatch (Withings Scanwatch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wearing time of smartwatch (daily)
Measured: 180 days
Longitudinal development of activity parameter: step count
Measured: 180 days
Longitudinal development of activity parameter: approximate distance traveled (meter)
Measured: 180 days
Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings Description: Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television
Measured: 180 days
Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings Description: Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton
Measured: 180 days
Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings Description: Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football, baseball, or tennis (singles)
Measured: 180 days
Longitudinal development of activity parameter: sum of all active time (seconds)
Measured: 180 days
Longitudinal development of activity parameter: approximate calories burned Time
Measured: 180 days
Longitudinal development of sleep parameter: time awake (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: number of times user woke up
Measured: 180 days
Longitudinal development of sleep parameter: time to sleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: total time in bed (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: total time asleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: ratio of sleep/time in bed
Measured: 180 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: Withings Sleep score Description: Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points
Measured: 180 days
Longitudinal development of cardiovascular parameter: average heartrate
Measured: 180 days
Longitudinal development of cardiovascular parameter: maximal heartrate
Measured: 180 days
Longitudinal development of cardiovascular parameter: minimum heartrate
Measured: 180 days
Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds) Description: Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.
Measured: 180 days
Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds) Description: Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.
Measured: 180 days
Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds) Description: Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.
Measured: 180 days
Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds) Description: Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate
Measured: 180 days
The Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is a clinical tool for assessing muscle spasticity in patients, particularly those with neurological conditions such as multiple sclerosis (MS). It assesses the resistance of a muscle to passive stretching and thus measures the degree of spasticity. The MAS helps to assess the severity of spasticity and monitor the effectiveness of treatment and disease progression. The scale ranges from 0 (no increased muscle tone) to 5 (limbs rigid in flexion and extension).
Measured: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
Secondary outcomes (11)
WHOQoL-BREF (World Health Organization Quality of Life Questionnaire Brief Version)
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: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Expanded Disability Status Scale (EDSS)
The Expanded Disability Status Scale (EDSS) is a scale used to measure the severity of disability in patients with multiple sclerosis (MS). It assesses neurological function based on factors such as mobility, coordination, vision and strength. The scale ranges from 0 (no disability) to 10 (death due to MS). The EDSS is used to track disease progression and make treatment decisions, with higher scores indicating greater disability.
Measured: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
Smartwatch Questionnaire
Questionnaire about smartwatch usage. Patients are presented with 17 statements about the smartwatches, focusing on practicality, usability, and everyday suitability. They can score each statement from 1 to 5, where 5 means strong agreement and 1 means strong disagreement.
Measured: 6 months (V3)
End of Dose Questionnaire (EOD)
The End-of-dose-phenomena-Questionnaire assesses the effectiveness of a treatment at the end of its dosing interval and asks about an increase in symptoms. Patients can state whether they have experienced a worsening of symptoms in recent weeks and, if so, for how many days and which migraine symptoms have worsened.
Measured: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
McCorkle and Young Symptom Distress Scale
The McCorkle and Young Symptom Distress Scale is an instrument for assessing the degree of distress caused by various physical symptoms. The scale consists of 13 symptoms (such as pain, nausea, fatigue, insomnia and shortness of breath) that are commonly experienced by patients. Patients rate each symptom on a scale of 1 to 5, with 1 being 'no distress' and 5 being 'extreme distress'. This scale can be used to determine which symptoms are the most distressing. This enables better symptom management and customised measures to improve the patient's quality of life.
Measured: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Multiple Sclerosis Impact Scale 29 (MSIS-29)
The Multiple Sclerosis Impact Scale 29 (MSIS-29) is a questionnaire of the impact of multiple sclerosis (MS) on patients' daily lives. It consists of 29 items divided into two sections: the physical impact (20 items) and the psychological impact (9 items) of MS. Each item is rated on a scale of 1 to 5, with a higher score indicating a greater impact. The MSIS-29 helps assess how MS affects physical function and emotional well-being and provides valuable insights for treatment planning and monitoring disease progression.
Measured: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Numeric Rating Scale (NRS)
The NRS is another tool used to assess pain intensity. It involves the patient rating their pain on a scale from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable." Both scales are widely used due to their simplicity and effectiveness in monitoring symptom severity.
Measured: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Montgomery-Asberg Depression Rating Scale (MADRS)
The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinical instrument for assessing the severity of depression in patients. It consists of 10 items that assess symptoms such as mood, guilt, sleep, appetite and concentration. Each item is scored on a scale from 1 to 7, with higher scores indicating more severe depression. The MADRS is commonly used to monitor changes in depressive symptoms and evaluate the effectiveness of treatment.
Measured: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Edmonton Symptom Assessment Scale (ESAS)
The Edmonton Symptom Assessment Scale (ESAS) is an instrument commonly used to assess the severity of symptoms in patients with advanced or terminal illnesses. It helps to assess the intensity of symptoms such as pain, fatigue, nausea, depression, anxiety, sleep disturbance, loss of appetite, breathlessness, general well-being and physical decline. Patients rate each symptom on a scale from 0 (no symptom) to 10 (worst possible symptom), which allows for quick and effective symptom monitoring. This scale helps to adjust treatment plans and improve the quality of care by tracking changes in symptoms over time.
Measured: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
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: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
EQ-5D-5L
EQ-5D-5L: is a standardized instrument for measuring health-related quality of life. It assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from no problems to extreme problems. Respondents rate their health state by selecting the most appropriate level for each dimension.
Measured: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start19 Oct 2023
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- 46 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
- NCT06937723
- Sponsor's protocol ID
- SMASH_1.0
- Acronym
- SMASH
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Monitoring Assessing Spasticity-related Health - A Prospective Multiple Sclerosis Study With Wearables
- ClinicalTrials.gov ID
- NCT06937723
- Acronym / sponsor ID
- SMASH / SMASH_1.0
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Spasticity, Smartwatch, Wearables, Digital health tools
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 22 Apr 2025 (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 of spasticity in patients with multiple sclerosis (MS) by employing multimodal monitoring techniques. By integrating digital biomarkers alongside clinical monitoring, the investigators aim to evaluate whether digital measurements are suitable for monitoring spasticity-related everyday limitations and to compare them with established clinical scores, blood analyses and questionnaires including sores on quality of life, sleep quality or activities of daily living.
Detailed description
The symptomatic treatment of spasticity in patients with multiple sclerosis (MS) is a major challenge for both patients and healthcare providers. However, monitoring and measuring the success or failure of treatments in clinical practice remains difficult. This is mainly due to the lack of clinical scores and biomarkers that can be easily and longitudinally collected. Existing scores (such as questionnaires and the Modified Ashworth scale) are rarely used in practice. In addition, the monitoring of side effects (such as dizziness, nausea and fatigue) is difficult in routine clinical practice and often leads to premature discontinuation or switching of treatment. As a result, therapeutic options are often exhausted prematurely. Continuous monitoring with sensitive assessments could enable a better understanding of spasticity treatment.
Approximately 50 patients with moderate and severe spasticity due to MS are to be included in the study. After inclusion, follow-up examinations are carried out every 12 weeks; a total of 3 visits are planned, including the baseline examination.
The study aims to improve the understanding of spasticity symptoms and assess them in patients through multimodal clinical and longitudinal digital measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS patients | – | Other: Device: Smartwatch (Withings Scanwatch)Patients with Multiple Sclerosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MS and 18 years or older
Key inclusion criteria (6 listed)
- ≥ 18 years of age
- Diagnosis of multiple sclerosis according to the McDonald criteria of 2017
- Presence of spasticity that requires medical treatment from a medical point of view
- own and use a smartphone with Android 8.1 (or higher version) or iOS 12.3 (or higher version)
- Able to operate a smartphone
Key exclusion criteria (4 listed)
- Missing informed consent
- Lack of declaration of consent
- Unwillingness or inability to use the smartphone app
- Any comorbidity that leads to impaired understanding or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. The decision will be made at the discretion of the investigators.
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 |
|---|---|---|
| Device: Smartwatch (Withings Scanwatch)All-day monitoring of patients via smartwatch | Other | MS patients |
Primary outcome
Wearing time of smartwatch (daily)
Time frame: 180 days
Longitudinal development of activity parameter: step count
Time frame: 180 days
Longitudinal development of activity parameter: approximate distance traveled (meter)
Time frame: 180 days
Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings Description: Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching television
Time frame: 180 days
Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings Description: Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton
Time frame: 180 days
Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings Description: Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football, baseball, or tennis (singles)
Time frame: 180 days
Longitudinal development of activity parameter: sum of all active time (seconds)
Time frame: 180 days
Longitudinal development of activity parameter: approximate calories burned Time
Time frame: 180 days
Longitudinal development of sleep parameter: time awake (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: number of times user woke up
Time frame: 180 days
Longitudinal development of sleep parameter: time to sleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: total time in bed (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: total time asleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: ratio of sleep/time in bed
Time frame: 180 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: Withings Sleep score Description: Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points
Time frame: 180 days
Longitudinal development of cardiovascular parameter: average heartrate
Time frame: 180 days
Longitudinal development of cardiovascular parameter: maximal heartrate
Time frame: 180 days
Longitudinal development of cardiovascular parameter: minimum heartrate
Time frame: 180 days
Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds) Description: Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.
Time frame: 180 days
Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds) Description: Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.
Time frame: 180 days
Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds) Description: Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.
Time frame: 180 days
Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds) Description: Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate
Time frame: 180 days
The Modified Ashworth Scale (MAS)
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Modified Ashworth Scale (MAS) is a clinical tool for assessing muscle spasticity in patients, particularly those with neurological conditions such as multiple sclerosis (MS). It assesses the resistance of a muscle to passive stretching and thus measures the degree of spasticity. The MAS helps to assess the severity of spasticity and monitor the effectiveness of treatment and disease progression. The scale ranges from 0 (no increased muscle tone) to 5 (limbs rigid in flexion and extension).
11 secondary outcomes
WHOQoL-BREF (World Health Organization Quality of Life Questionnaire Brief Version)
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Expanded Disability Status Scale (EDSS)
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
Smartwatch Questionnaire
Time frame: 6 months (V3)
End of Dose Questionnaire (EOD)
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
McCorkle and Young Symptom Distress Scale
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Multiple Sclerosis Impact Scale 29 (MSIS-29)
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Numeric Rating Scale (NRS)
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
The Edmonton Symptom Assessment Scale (ESAS)
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
Sleep-Questionnaire
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
EQ-5D-5L
Time frame: Screening + Baseline (V1), 3 months (V2), 6 months (V3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 Multiple Sclerosis, 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Pawlitzki, PD Dr. med. (0049 21181-17889, 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?
Wearing time of smartwatch (daily) (time frame: 180 days). The study lists 25 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 22 Apr 2025.