Cognitive Stimulation in Patients With Sclerosis Multiple

NCT06714487 | Completed DMC

• 1 other identifier: IISPV-juguEMos-HTVC
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; play and Playthings; cognitive therapy

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  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 .

  Quality of life (baseline, pre intervention) at 6 months (post intervention)

Study Arms (2)

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.

Other: cognitive stimulation through games

Interventions

cognitive stimulation through games OTHER

cognitive stimulation through games

Intervention with games

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 3, 2024
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: May 1, 2017
• Last Updated: December 3, 2024

Record last verified: 2024-11