Multiple SclerosisJuguEMosNCT06714487
Cognitive Stimulation in Patients With Sclerosis Multiple
A study testing cognitive stimulation through games in people with Multiple Sclerosis, run by Institut Investigacio Sanitaria Pere Virgili.
Trial summary
The primary objective of the study is to determine if the training for 6 months with a specific set of games ( previously selected according to the cognitive domain stimulate : attention, memory , executive functions and processing speed ) , so improve significant neuropsychological performance of patients with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- cognitive stimulation through games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to May 2017
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of RRMS or SPMS according to Poser criteria (1983) and McDonald (2001).
- Degree of disability between 1 ( clinical signs without disability) and 5.5 (capable of walk 100 meters without aid or rest , disability severe enough to prevent the activities of the whole ) day as the Disability Scale Kurtze (EDSS , 1983).
- Basic treatment for first-line MS ( immunomodulators).
- Complaints cognitive, functional gradation in the scale of dementia GDS ( Global Dementia Staging ) of Reisberg (1982 ) 2 and 4 .
- Patients who have mild to moderate cognitive impairment (have between 20 and 40 % of the altered neuropsychological tests).
- Signed informed consent .
Who cannot join
- Cognitive impairment associated with other medical diseases (Alzheimer's, stroke, Parkinson's disease, kidney disease, respiratory, hepatic, endocrine or hematological).
- Diagnosis of primary psychiatric disease with cognitive impairment in accordance with DSM-IV-TR criteria: schizophrenia, bipolar disorder, personality…
- Diagnosis or history of substance abuse or dependence.
- Score the Beck Depression Inventory II (BDI-II) greater than or equal to 30.
- Low Intelectual coeficient, inferred through obtaining a scale score less than 4 on the Vocabulary subtest of the WAIS-IV.
- Evidence of delusions, confusion or other disturbances of consciousness.
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- Severe sensory deficits (visual and / or auditory)or functional illiteracy in which neuropsychological study can not be carried out.
- Patients treated with immunosuppressive drugs base or second line.
- Patients who are already receiving treatment or have cognitive rehabilitation received in the last 12 months.
About this study
Official title: JUGUEMOS - Cognitive Stimulation Through Games : a New Active Aging Approach to Enhance Users' Everyday Challenges Sclerosis Multiple
The primary objective of the study is to determine if the training for 6 months with a specific set of games ( previously selected according to the cognitive domain stimulate : attention, memory , executive functions and processing speed ) , so improve significant neuropsychological performance of patients with Multiple Sclerosis Sender Recurrent ( RRMS ) and secondary progressive multiple sclerosis (SPMS ) , your mood and your quality of life.
Design : randomized clinical trial with a control group , coordinated a multicenter sample preselected patients.
Read the detailed description
A total of 80 patients with RRMS or SPMS, which will be evaluated at baseline were included regarding various clinical, demographic, neuropsychological, psychometric and operational variables.
Subsequently patients will be randomized (in a ratio of 1: 1) to two groups different. The experimental group (EG = 40 patients) participate in a program of stimulation Cognitive group, while the control group (CG = 40 patients) did not receive any experimental intervention. All patients continue to receive drug treatment MS according to the standard treatment algorithms. At 6 months, once patients GE have completed treatment of cognitive stimulation, 80 patients will be reassessed respect to the same variables neuropsychological, psychometric and operation that had It has been evaluated at baseline.
Cognitive differences, clinics and operating both at baseline and at 6 be studied months among patients of GE responders and nonresponders to treatment stimulation cognitive and GC.
- Conditions
- Multiple Sclerosis
- Being tested
- cognitive stimulation through games
- Keywords
- Multiple sclerosis, play and Playthings, cognitive therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive stimulation through gamesOther
cognitive stimulation through games
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Neuropsychological evaluation including pre and 6 months without cognitive stimulation through games. |
| Intervention with games | Experimental | Neuropsychological evaluation including pre and 6 months with cognitive stimulation three times a week through games. Receives: Other: cognitive stimulation through games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capacity to stimulate the functions cognitive, is why cognitive stimulation through strategies and neuropsychological specific set of board games, improve cognitive performance in patients with RRMS and PMSC .
Determine whether the training for 6 months with a specific set of table games (previously selected according to stimulate the cognitive domain: attention test score, memory test score, functions executive and processing speed test score, improved significantly, neuropsychological performance of patients with RRMS or SPMS questionnaires, their mood and quality of life, specify the measurement used with questionnaires. The project duration is 24 months.
An intervention is applied for six months to two study groups. And it is expected to see a minimum difference of 1.5 points in the postintervention test scores.
Phonetic verbal fluency test score; NEURONORMA project: words P in 1 minute). Subjects have to produce as many words as possible beginning with the letter P for 60 seconds. The total number of correct answers is analyzed, besides collecting errors and repetitions. WAIS-IV (score; is the number correctly coded from 0-133 in 120 seconds), HADS (score; from 0 to 21).
Measured: Cognitive performance baseline (pre intervention) at 6 months (post intervention)
Secondary outcomes (2)
Positive social interaction generated by the group reinforcement groups treatment will lead to improved mood of its participants.
Positive social interaction generated by the group reinforcement groups treatment will lead to improved mood of its participants. The EVEA scale will measure mood states. (points of total score (10)).
Measured: Social interaction, baseline (pre intervention) at 6 months (post intervention)
Cognitive improvement achieved after participation in a group of cognitive stimulation through strategies and neuropsychological games, improve the quality of life Patients with RRMS and SPMS .
Cognitive improvement as assessed by the MSQOL-54 scale (baseline, pre intervention) at 6 months (post intervention) at intervention group.
The project duration is 24 months. Quality of life pre and post-intervention measured by Multiple Sclerosi Quality of Life MSQOL-54, is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. Quality of Life Questionnaire,: the total score obtained in the questionnaire will be recorded.
Assessment of Quality of life through the following dimensions: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, emotional, fatigue or energy, perception of general health, social function and changes in health status. The total score obtained in the questionnaire will be recorded.
Measured: Quality of life (baseline, pre intervention) at 6 months (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study startFeb 2016
- Primary completionSep 2016
- Study completionMay 2017
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714487
- Sponsor's protocol ID
- IISPV-juguEMos-HTVC
- Acronym
- JuguEMos
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2015
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JUGUEMOS - Cognitive Stimulation Through Games : a New Active Aging Approach to Enhance Users' Everyday Challenges Sclerosis Multiple
- ClinicalTrials.gov ID
- NCT06714487
- Acronym / sponsor ID
- JuguEMos / IISPV-juguEMos-HTVC
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, play and Playthings, cognitive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 3 Dec 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.
The primary objective of the study is to determine if the training for 6 months with a specific set of games ( previously selected according to the cognitive domain stimulate : attention, memory , executive functions and processing speed ) , so improve significant neuropsychological performance of patients with Multiple Sclerosis Sender Recurrent ( RRMS ) and secondary progressive multiple sclerosis (SPMS ) , your mood and your quality of life.
Design : randomized clinical trial with a control group , coordinated a multicenter sample preselected patients.
Detailed description
A total of 80 patients with RRMS or SPMS, which will be evaluated at baseline were included regarding various clinical, demographic, neuropsychological, psychometric and operational variables.
Subsequently patients will be randomized (in a ratio of 1: 1) to two groups different. The experimental group (EG = 40 patients) participate in a program of stimulation Cognitive group, while the control group (CG = 40 patients) did not receive any experimental intervention. All patients continue to receive drug treatment MS according to the standard treatment algorithms. At 6 months, once patients GE have completed treatment of cognitive stimulation, 80 patients will be reassessed respect to the same variables neuropsychological, psychometric and operation that had It has been evaluated at baseline.
Cognitive differences, clinics and operating both at baseline and at 6 be studied months among patients of GE responders and nonresponders to treatment stimulation cognitive and GC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Neuropsychological evaluation including pre and 6 months without cognitive stimulation through games. |
| Intervention with games | Experimental | Other: cognitive stimulation through gamesNeuropsychological evaluation including pre and 6 months with cognitive stimulation three times a week through games. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of RRMS or SPMS according to Poser criteria (1983) and McDonald (2001).
- Degree of disability between 1 ( clinical signs without disability) and 5.5 (capable of walk 100 meters without aid or rest , disability severe enough to prevent the activities of the whole ) day as the Disability Scale Kurtze (EDSS , 1983).
- Basic treatment for first-line MS ( immunomodulators).
- Complaints cognitive, functional gradation in the scale of dementia GDS ( Global Dementia Staging ) of Reisberg (1982 ) 2 and 4 .
- Patients who have mild to moderate cognitive impairment (have between 20 and 40 % of the altered neuropsychological tests).
Key exclusion criteria (9 listed)
- Cognitive impairment associated with other medical diseases (Alzheimer's, stroke, Parkinson's disease, kidney disease, respiratory, hepatic, endocrine or hematological).
- Diagnosis of primary psychiatric disease with cognitive impairment in accordance with DSM-IV-TR criteria: schizophrenia, bipolar disorder, personality…
- Diagnosis or history of substance abuse or dependence.
- Score the Beck Depression Inventory II (BDI-II) greater than or equal to 30.
- Low Intelectual coeficient, inferred through obtaining a scale score less than 4 on the Vocabulary subtest of the WAIS-IV.
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 |
|---|---|---|
| cognitive stimulation through gamescognitive stimulation through games | Other | Intervention with games |
Primary outcome
Capacity to stimulate the functions cognitive, is why cognitive stimulation through strategies and neuropsychological specific set of board games, improve cognitive performance in patients with RRMS and PMSC .
Time frame: Cognitive performance baseline (pre intervention) at 6 months (post intervention)
Determine whether the training for 6 months with a specific set of table games (previously selected according to stimulate the cognitive domain: attention test score, memory test score, functions executive and processing speed test score, improved significantly, neuropsychological performance of patients with RRMS or SPMS questionnaires, their mood and quality of life, specify the measurement used with questionnaires. The project duration is 24 months. An intervention is applied for six months to two study groups. And it is expected to see a minimum difference of 1.5 points in the postintervention test scores. Phonetic verbal fluency test score; NEURONORMA project: words P in 1 minute). Subjects have to produce as many words as possible beginning with the letter P for 60 seconds. The total number of correct answers is analyzed, besides collecting errors and repetitions. WAIS-IV (score; is the number correctly coded from 0-133 in 120 seconds), HADS (score; from 0 to 21).
2 secondary outcomes
Positive social interaction generated by the group reinforcement groups treatment will lead to improved mood of its participants.
Time frame: Social interaction, baseline (pre intervention) at 6 months (post intervention)
Cognitive improvement achieved after participation in a group of cognitive stimulation through strategies and neuropsychological games, improve the quality of life Patients with RRMS and SPMS .
Time frame: Quality of life (baseline, pre intervention) at 6 months (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive stimulation through games in people with Multiple Sclerosis, run by Institut Investigacio Sanitaria Pere Virgili.
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 9 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: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capacity to stimulate the functions cognitive, is why cognitive stimulation through strategies and neuropsychological specific set of board games, improve cognitive performance in patients with RRMS and PMSC . (time frame: Cognitive performance baseline (pre intervention) at 6 months (post intervention)). 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 3 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.