Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis
NCT06303024, Not applicable, Unknown, Fondazione Don Carlo Gnocchi ETS
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis | ClinicalTrials.gov |
| NCT number | NCT06303024 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 140 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondazione Don Carlo Gnocchi ETS | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis, Relapsing-Remitting | ClinicalTrials.gov |
| Interventions | personalized combined physical and cognitive intervention | ClinicalTrials.gov |
| First posted | 2024-03-12 | ClinicalTrials.gov |
| Last updated | 2024-03-12 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Symbol Digit Modalities Test (SDMT) | baseline and 1 year followup cohort 1; baseline, 3 months and 1 year followup cohort 2 | The SDMT is a simple matching task that requires the participant to refer to a reference key, in order to correctly match a geometric symbol with the corresponding number. Participant will be under a 90 second time constraint to quickly and correctly match each pair. | ClinicalTrials.gov |
| Primary | California Verbal Learning Test second edition (CVLT-II) | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | The CVLT test begins with the examiner reading a list of 16 words, participants are then instructed to report as many of the words as they can remember. After recall is recorded, the entire list is read again, altogether, there are five learning trials. | ClinicalTrials.gov |
| Primary | Brief Visuo-Spatial Memory Test- Revised (BVMT-R) | baseline and 1 year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | Participants are presented with six abstract designs for 10 seconds, the display is then removed from view and participant are instructed to draw the designs from memory via pencil on paper. Each design is scored from 0 to 2 points representing accuracy and location. There are three learning trials. | ClinicalTrials.gov |
| Primary | Word list generation (WLG) | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | the subject has to say as many words from the fruit and vegetable categories as they can think of in one and a half minutes | ClinicalTrials.gov |
| Primary | Stroop test | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | the reading time of the stimuli in the interference condition is assessed: there are colours written but the colour of the ink is different from the written word, the subject has to say the colour of the ink in which the word is written | ClinicalTrials.gov |
| Primary | Test Intelligenza Breve (TIB) | baseline cohort 1 and baseline cohort 2 | evaluation of the IQ estimation, the subject reads words with regular and irregular accents and takes the number of errors of words with irregular accents | ClinicalTrials.gov |
| Primary | 9 hole peg test (9HPT) | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | to measure finger dexterity, the subject must take the pegs one at a time with the dominant hand and then with the other hand and insert them as quickly as possible into the holes and remove them | ClinicalTrials.gov |
| Primary | The Hospital Anxiety and Depression Scale (HADS) | baseline and 1year followup cohort 1; baseline, 3 months and 1 year followup cohort 2 | to measure anxiety and depression | ClinicalTrials.gov |
| Primary | Beck Depression Inventory second edition | baseline and 1year followup cohort 1; baseline, end 3 months and 1year followup cohort 2 | to measure depression | ClinicalTrials.gov |
| Primary | The Modified Fatigue Impact Scale (MFIS) | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | to measure fatigue | ClinicalTrials.gov |
| Primary | The Multiple Sclerosis Walking Scale (MSWS-12) | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | evaluate the participants subjective impact of walking. | ClinicalTrials.gov |
| Primary | Multiple Sclerosis Impact Scale (MSIS-29-V2) | baseline and 1yearfollowup cohort 1; baseline, 3 months and 1year followup cohort 2 | to evaluate the participants impact of Multiple Sclerosis. | ClinicalTrials.gov |
| Primary | Multiple Sclerosis Quality of Life-54 (MSQOL-54) | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | to evaluate quality of life | ClinicalTrials.gov |
| Primary | six minutes walking test (6MWT) | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | to measure the distance a subject can travel by walking as fast as possible on a flat surface in six minutes. | ClinicalTrials.gov |
| Primary | Romberg test | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | to assess balance | ClinicalTrials.gov |
| Primary | handgrip test | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | a strength evaluation test | ClinicalTrials.gov |
| Primary | cognitive-motor interference | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | impact of a simple cognitive test - verbal fluency on a randomly extracted letter - on motor performances | ClinicalTrials.gov |
| Primary | Timed 25-foot walk | baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2 | is a quantitative mobility and leg function performance test based on a timed 25-walk. | ClinicalTrials.gov |
| Primary | brain MRI scan | baseline and 1 year followup cohort 1 and 2 | to evaluate the presence of new/enlarging T2 lesions, new gadolinium-positive lesions, and volumetric analyses | ClinicalTrials.gov |
| Primary | International Physical Activity Questionnaire (IPAQ) | baseline and 1 year followup cohort 1 and 2 | to assess the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. | 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 4
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 |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary 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)