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Cognitive Stimulation in Patients With Sclerosis Multiple

NCT ID: NCT06714487

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-05-31

Brief Summary

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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

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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

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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No intervention

Neuropsychological evaluation including pre and 6 months without cognitive stimulation through games.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention with games

Neuropsychological evaluation including pre and 6 months with cognitive stimulation three times a week through games.

Group Type EXPERIMENTAL

cognitive stimulation through games

Intervention Type OTHER

cognitive stimulation through games

Interventions

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cognitive stimulation through games

cognitive stimulation through games

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 .

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Investigacio Sanitaria Pere Virgili

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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IISPV-juguEMos-HTVC

Identifier Type: -

Identifier Source: org_study_id