Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland)
NCT06526364, Recruiting, University Hospital, Basel, Switzerland
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland) | ClinicalTrials.gov |
| NCT number | NCT06526364 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Basel, Switzerland | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive | ClinicalTrials.gov |
| Interventions | All participants will be asked to provide data and samples for collection and analysis. | ClinicalTrials.gov |
| First posted | 2024-07-29 | ClinicalTrials.gov |
| Last updated | 2025-12-26 | ClinicalTrials.gov |
Registered outcomes 26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Set of biomarkers | 2029 | To identify clinical, imaging and omics characteristics associated with early MS and with transitioning phases to progressive MS, a set of biomarkers is derived that allows in the future to better characterize the disease clinical phenotype and progression, the functional impairment of MS patients in different disease stages, and either associated with early MS or with transitioning phase to progressive MS, as an aid to assist clinicians in applying treatment change. | ClinicalTrials.gov |
| Secondary | Expanded Disability Status Scale (EDSS) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Expanded Disability Status Scale (EDSS) is assessed. The EDSS is a standardized method used to quantify disability in MS patients. The scale ranges from 0 to 10, with lower scores indicating minimal or no disability and higher scores indicating severe disability. Scores are determined based on assessments of motor function, sensory function, coordination, and other neurological functions. | ClinicalTrials.gov |
| Secondary | 9-Hole Peg Test (9-HPT) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the 9-Hole Peg Test (9-HPT) is performed. The 9-HPT evaluates manual dexterity by measuring the time it takes for the participant to move nine pegs from a box into nine holes on a board and back. Lower times indicate better dexterity and hand function, while higher times suggest greater impairment. The test will be carried out twice per hand, starting with the dominant hand, and the best performance will be used. | ClinicalTrials.gov |
| Secondary | Timed 25-Foot Walk (T25FW) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Timed 25-Foot Walk (T25FW) is performed. The T25FW measures the time it takes for the patient to walk a distance of 25 ft (7,62 m) in their usual manner. Shorter times indicate better walking ability and mobility, while longer times suggest greater impairment. | ClinicalTrials.gov |
| Secondary | Stroop Test (Victoria Version) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Stroop Test (Victoria Version) is performed. The Stroop Test measures processing speed and inhibition ability. First round: Participant is presented with 24 coloured dots and is asked to name the colour of the dots as fast as possible. Second round: Participant sees coloured random words (when, and, hard, over) and is asked to name the colour of each word as fast as possible. Third round: Participants is presented with 24 coloured words spelling colours (and the printed colour of the word is not the same as spelled colour), and is asked to name the printed colour as fast as possible. The test gives three scores based on the number of completed items in each round, and interference scores can be calculated. | ClinicalTrials.gov |
| Secondary | Symbol Digit Modalities Test (SDMT) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Symbol Digit Modalities Test (SDMT) is performed. The SDMT measures information processing speed. The participant is presented with a key, matching symbols to numbers (1-9). The participant must then use this key to orally (or in written form) match symbols to digits from list during 90 seconds and the number of correctly matched symbols are counted. Higher scores indicate better cognitive processing speed and efficiency, while lower scores suggest slower processing speed and potential cognitive impairment. | ClinicalTrials.gov |
| Secondary | Trail Making Test A&B (TMT A&B) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Trail Making Test A\&B (TMT A\&B) is performed. The TMT A\&B evaluates information processing speed and mental flexibility. In part A, the participants are asked to connect numbers in ascending order (randomly spread out on a sheet) with a pencil as fast as they can. In part B there is an additional sequence (alphabet), also randomly spread out on the sheet. The participants must now connect switching from number to letter (e.g., 1-A-2-B-3-C…) as fast as they can. In each part, the result is measured as time to completion of the task. Lower completion times indicate better cognitive functioning, while higher times may suggest difficulties with cognitive flexibility and processing speed. | ClinicalTrials.gov |
| Secondary | Multiple Sclerosis Inventory of Cognition (MUSIC) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Multiple Sclerosis Inventory of Cognition (MUSIC) is performed. The MUSIC evaluates various cognitive domains such as memory, attention, processing speed, and executive function. The number of correctly associated words within 1 min is measured, not counting in repetitions or missed alternations. Higher scores indicate better cognitive performance, while lower scores suggest cognitive impairment. | ClinicalTrials.gov |
| Secondary | Digit span backwards (DSB) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Digit span backwards (DSB) is performed. The DSB assesses working memory. The tester reads out a series of random digits, which the participants must repeat starting from the last digit going to the first e.g.: tester: "1, 2, 3", participant: "3, 2, 1". The test starts with 3 digits, after each successful round (2 series of digits) the series increases 1 digit. The test goes on until the participant fails twice to reproduce the series backwards. | ClinicalTrials.gov |
| Secondary | Rey-Osterrieth Complex Figure Test (ROCF) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Rey-Osterrieth Complex Figure Test (ROCF) is performed. The ROCF tests visuo-constructive abilities, visual memory and executive functioning (mainly planning). Participants are asked to copy and memorise a complex figure, then draw from memory after \~ 3 minutes and draw once more after \~ 30 minutes. The test proposed by Taylor (1959), which is an adapted version of the original, is used. Scoring is determined by the number of correctly drawn sub-sections of the complex figure and their position. The maximum score is 36 (18 subsections with 2 possible points per subsection (1 for correctly drawn, 1 for correctly placed). Higher scores indicate better visuospatial and memory performance, while lower scores suggest impairments in these cognitive functions. | ClinicalTrials.gov |
| Secondary | Verbal Learn and Memory Test (VLMT) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Verbal Learn und Memory Test (VLMT) is performed. The VLMT assesses verbal learning and memory by having participants memorize and recall 15 words read aloud by a rater. This process is repeated five times with new word lists introduced between trials. The participant recalls the initial list immediately and again after a 20-30 minute delay. Scores range from 0 to 75 for learning trials and 0 to 15 for immediate and delayed recall, where higher scores indicate better memory performance and lower scores indicate cognitive challenges. The VLMT is the German precursor to the California auditory-verbal learning test. | ClinicalTrials.gov |
| Secondary | Near vision acuity test | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Near vision acuity test is performed. The Near Vision Acuity Test measures how well a person can see and read at close distances, using a common near vision chart according to manufacturer instructions. Common charts yield ratio values from 0.1 to 1.2. The test is non-verbal. Higher scores indicate better near vision acuity, while lower scores suggest difficulties with seeing close-up details. | ClinicalTrials.gov |
| Secondary | Contrast vision test (Pelli-Robson low-contrast chart) | Baseline and once a year for up to 5 years | To determine the individual disease activity scores and their evolution since baseline (improvement/worsening), the Contrast vision test (Pelli-Robson low-contrast chart) is performed. This is a contrast discrimination test to detect visual disturbances (with equally large letters of decreasing contrast, organized in triplets, to be read at a distance of 1 m). The participant is asked to name the letters and the test continues until two or more errors are made for a triplet of letters. Contrast sensitivity is determined by the last triplet in which the participant can correctly name two of three letters, and the chart's log sensitivity range is from 0 to 2.25. | ClinicalTrials.gov |
| Secondary | Short-form Food Frequency Questionnaire (SFFFQ) | Baseline and once a year for up to 5 years | The Short-form Food Frequency Questionnaire is used to ask five questions about the typical weekly diet. | ClinicalTrials.gov |
| Secondary | Fatigue Severity Scale (FSS) | Baseline every 6 months for up to 5 years | To assess the quality of life and disease activity and their evolution since baseline (improvement/worsening), the Fatigue Severity Scale (FSS) is distributed through the Healios+Me app. The FSS is a self-report questionnaire that measures the severity of fatigue and how it has interfered with certain activities during the past 14 days. Scores range from 1 to 7 for each statement, with higher scores indicating greater severity of fatigue symptoms. Lower scores suggest milder fatigue symptoms or less impact on daily life. | ClinicalTrials.gov |
| Secondary | Multiple Sclerosis Impact Scale (MSIS-29) | Baseline every 6 months for up to 5 years | To assess the quality of life and disease activity and their evolution since baseline (improvement/worsening), the Multiple Sclerosis Impact Scale (MSIS-29) is distributed through the Healios+Me app. The MSIS-29 is a self-report questionnaire that measures the physical and psychological impact of MS during the past 2 weeks. Scores range from 0 to 100 for each subscale, with higher scores indicating a greater impact of MS on physical and psychological well-being. Lower scores suggest less impact and better quality of life in these domains. | ClinicalTrials.gov |
| Secondary | MS Symptom Tracker | Baseline every 6 months for up to 5 years | To assess the quality of life and disease activity and their evolution since baseline (improvement/worsening), the MS Symptom Tracker is integrated in the Healios+Me app. The MS Symptom Tracker consists of questions regarding symptoms experienced during the past 2 weeks. | ClinicalTrials.gov |
| Secondary | Relapse reporting | Baseline every 6 months for up to 5 years | To assess the quality of life and disease activity and their evolution since baseline (improvement/worsening), Relapse reporting is integrated through the Healios+Me app. It allows patients to report in the app when a relapse has occurred, following a structured questionnaire. | ClinicalTrials.gov |
| Secondary | Multiple Sclerosis Quality of Life-54 (MSQoL-54) | Baseline and once a year for up to 5 years | To assess the quality of life and disease activity and their evolution since baseline (improvement/worsening), the Multiple Sclerosis Quality of Life-54 (MSQoL-54) is performed. The MSQoL-54 is a self-report questionnaire on quality of life with 36 generic and 18 MS-specific items. Scores are calculated for each domain and range from 0 to 100, with higher scores indicating better quality of life. Lower scores indicate poorer quality of life in the respective domains assessed by the questionnaire. | ClinicalTrials.gov |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | Baseline and once a year for up to 5 years | To assess the quality of life and disease activity and their evolution since baseline (improvement/worsening), the Hospital Anxiety and Depression Scale (HADS) is performed. The HADS is a self-report questionnaire on anxiety and depression symptoms with 14 items. Each item is scored on a scale from 0 to 3, with higher scores indicating higher levels of anxiety or depression. Total scores for each subscale (anxiety and depression) range from 0 to 21, where higher scores indicate more severe symptoms of anxiety or depression. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)