Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients
NCT04694534, Not applicable, Recruiting, Lille Catholic University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients | ClinicalTrials.gov |
| NCT number | NCT04694534 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Lille Catholic University | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis, Memory, Learning | ClinicalTrials.gov |
| Interventions | Serious game, Usual HAS care | ClinicalTrials.gov |
| First posted | 2021-01-05 | ClinicalTrials.gov |
| Last updated | 2025-09-04 | ClinicalTrials.gov |
Registered outcomes 23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in the California Verbal Learning Test (CVLT) | Change from baseline at 4 and 10 months | The California Verbal Learning Test (CVLT) begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible. | ClinicalTrials.gov |
| Primary | Change in the Brief Visuo-spatial Memory Test (BVMT) | Change from baseline at 4 and 10 months | In the Brief Visuospatial/lMemory Test six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12. | ClinicalTrials.gov |
| Primary | Change in the Symbol Digit Modalities Test (SDMT) | Change from baseline at 4 and 10 months | The Symbol Digit Modalities Test (SDMT) presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Patients are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure: the number correct. | ClinicalTrials.gov |
| Secondary | Change in the Auditory-verbal spans in direct or reverse order | Change from baseline at 4 and 10 months | This assessment is required to evaluate short time memory and working memory. | ClinicalTrials.gov |
| Secondary | Change in the Stroop Color-Word Test | Change from baseline at 4 and 10 months | This assessment is required to evaluate inhibition capacities and sensitivity to interference. | ClinicalTrials.gov |
| Secondary | Change in the Trail Making Test | Change from baseline at 4 and 10 months | This assessment is required to evaluate cognitive flexibility abilities. | ClinicalTrials.gov |
| Secondary | Change in the Categorical and phonemic verbal fluency test | Change from baseline at 4 and 10 months | This test is required to evaluate the spontaneous flexibility abilities. | ClinicalTrials.gov |
| Secondary | Change in the Tower of London test | Change from baseline at 4 and 10 months | This test is required to assess planning capacities. | ClinicalTrials.gov |
| Secondary | Change in the Commission test | Change from baseline at 4 and 10 months | This test assesses planning skills in a greener context than the Tower of London test. | ClinicalTrials.gov |
| Secondary | Change in the Concentrated Attention Test | Change from baseline at 4 and 10 months | This assessment is required to evaluate selective attention. | ClinicalTrials.gov |
| Secondary | Change in the Paced Auditory Serial Addition Task (PASAT) | Change from baseline at 4 and 10 months | This assessment is required to evaluate information processing speed and sustained attention. | ClinicalTrials.gov |
| Secondary | Change in the Mac Nair Scale | Change from baseline at 4 and 10 months | This self-evaluation is required to assess cognitive complaint. It is a 39-items questionnaire corresponding to symptoms. Every symptom is noted on an ordinal scale in 5 steps.It is a scale with 5 degrees of severity measuring the frequency of disorders as follows: 4 = very often, 3 = often, 2 = sometimes, 1 = rarely, 0 = never. | ClinicalTrials.gov |
| Secondary | Change in the IPA (Participation and Autonomy Impact) Form | Change from baseline at 4 and 10 months | This test is focused on the subject social participation and autonomy. is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The standard cut-off scores are as follows: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. | ClinicalTrials.gov |
| Secondary | Change in the BDI-II Scale (Beck Depression Inventory II) | Change from baseline at 4 and 10 months | This scale is required to assess participants depressive orders. This is a 21-items self-questionnaire. Every item is rated from 0 (no problem) to 3 (maximum symptom severity). The depressive syndrome severity total score presents 4 intensity levels : 0-11 (no depression), 12-19 (mild depression), 20-27 (medium depression), 27 (severe depression). | ClinicalTrials.gov |
| Secondary | Change in the State-Trait Anxiety Inventory (STAI Y) | Change from baseline at 4 and 10 months | This scale is used to evaluate the participants level anxiety. It is a 20-items questionnaire. The patients identifie the frequency with which they usually feel the symptoms listed on a four-point Likert-type scale variant from 1: "never" on the 1 point side to 4: "always" on the 4 point side. The overall score varies between 20 and 80. | ClinicalTrials.gov |
| Secondary | Change in the Visual Analogue Scale for Fatigue | Change from baseline at 4 and 10 months | This scale allows patients to assess their fatigue. The patients locate their fatigue intensity on a 100-millimeters horizontal line.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | ClinicalTrials.gov |
| Secondary | Change in the Apparent validity | Change from baseline at 4 and 10 months | Face validity is based on a subjective assessment of the instrument's validity to assess the patient's attitude towards the tool, its degree of involvement and its acceptability. | ClinicalTrials.gov |
| Secondary | Change in the EDSS score (Expanded disability status scale) | Change from baseline at 4 and 10 months | This score is required to assess the patients functional and neurological level disability. This scale stretchs from 0 (no complaint and normal examen) to 10 (death caused by MS). The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. | ClinicalTrials.gov |
| Secondary | Frequency of game play per Week (in days) | Observance at 4 months | This outcome is required to evaluate the instructions observance and play practices. | ClinicalTrials.gov |
| Secondary | Game session lenght | Observance at 4 months | This outcome is required to evaluate the instructions observance and play practices. | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 38033375 | DERIVED | PubMed |
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 8
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 |
|---|---|---|
| Symbol Coding | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Tower Planning | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | 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)