An interventional study of cognitive stimulation through games in Multiple Sclerosis, sponsored by Institut Investigacio Sanitaria Pere Virgili. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Institut Investigacio Sanitaria Pere Virgili · Not applicable, Interventional, and Prevention
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.
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.
3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's enrollment of 80 is above the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Institut Investigacio Sanitaria Pere Virgili is the lead sponsor of 38 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Neuropsychological evaluation including pre and 6 months without cognitive stimulation through games.
Neuropsychological evaluation including pre and 6 months with cognitive stimulation three times a week through games.
Other: cognitive stimulation through games
cognitive stimulation through games
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).
Time frame: Cognitive performance baseline (pre intervention) at 6 months (post intervention)
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)).
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 .
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.
Time frame: Quality of life (baseline, pre intervention) at 6 months (post intervention)
No study locations are listed for this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Institut Investigacio Sanitaria Pere Virgili