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Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT02738034
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Regina Silva Paradela, University of Sao Paulo General Hospital

Brief Summary:
Systemic arterial hypertension is a disease with high prevalence in several countries, including Brazil. Many studies have correlated hypertension with accelerated loss of cognitive function, especially executive functions. There is some evidence that working memory (WM) is compromised in these populations. However, some computerized training has been developed to rehabilitate the WM, and among them the investigators highlight the Cogmed. Thus, the aim of this study is to evaluate the effects of Cogmed training in the performance of WM and attention of hypertensive patients, as well as the impact of training in the structure and brain function.

Condition or disease Intervention/treatment Phase
Hypertension Other: Cogmed Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment: a Randomized Clinical Trial
Study Start Date : April 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Adaptive training group
The intervention group will be composed of hypertensive participants with cognitive decline that will be submitted to the training program (Cogmed) for approximately 10 weeks. Across training, task difficulty was adjusted as a function of individual performance.
Other: Cogmed
The Cogmed is computer software designed to train visuospatial and audio-verbal working memory, and other functions associated with working memory: attention, focus and impulsiveness. It has three versions adapted to different age groups: Cogmed for younger children, about 4-7 years, which are not yet so familiar with numbers and letters; Cogmed for children over 7 years and adolescents; and Cogmed for youth and adults over 18 years. In this study we will use the version for youth and adults over 18 years.

Active Comparator: Active control Group
In the control group, hypertensive patient will be submitted to a set of online games available on the internet and previously determined. In this way, the control group will receive the same motivation, as well as will be engaged in computerized activities, in the same way as the experimental group. The difference is that these varied games do not provide any type of intense and adaptive training, at the same time as they do not stimulate any specific cognitive function.
Other: Cogmed
The Cogmed is computer software designed to train visuospatial and audio-verbal working memory, and other functions associated with working memory: attention, focus and impulsiveness. It has three versions adapted to different age groups: Cogmed for younger children, about 4-7 years, which are not yet so familiar with numbers and letters; Cogmed for children over 7 years and adolescents; and Cogmed for youth and adults over 18 years. In this study we will use the version for youth and adults over 18 years.




Primary Outcome Measures :
  1. Backward Digits Test / Letter-Number Sequencing (WAIS-III): total score (sum of right answers) [ Time Frame: three years ]
  2. VBM (Voxel based morphometry): clusters of increased Gray Matter (GM) volume in the Prefrontal and Parietal Cortex [ Time Frame: three years ]
  3. DTI (diffusion tensor imaging): absolute values of Fractional Anisotropy (FA) [ Time Frame: three years ]
  4. Resting State: total values of BOLD (blood-oxygen-level dependent) in the default mode network (DMN) [ Time Frame: three years ]
  5. Functional Magnetic Ressonance Imaging: total values of BOLD (blood-oxygen-level dependent) during working memory task [ Time Frame: three years ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals of both genders, of any ethnicity
  • Signing the consent form
  • Access to computer with internet at home
  • Inexperienced to computerized cognitive training
  • Hypertensive pre-diagnosed
  • Basic schooling of four years
  • Cognitive impairment

Exclusion Criteria:

  • Marked functional limitation
  • Cognitive limitation or serious communication
  • Severe neurological and psychiatric diseases
  • Stroke history, head trauma or substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738034


Contacts
Contact: Regina S Paradela 55 11 988648735 regina@paradela.net
Contact: Maria Claudia Irigoyen 55 11 26615006 maria.irigoyen@incor.usp.br

Locations
Brazil
Regina Silva Paradela Recruiting
Sao Paulo, São Paulo, Brazil, 05403-900
Contact: Regina Paradela, PhD Student         
Sponsors and Collaborators
University of Sao Paulo General Hospital

Responsible Party: Regina Silva Paradela, PhD student, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02738034     History of Changes
Other Study ID Numbers: CogDoc2016
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Keywords provided by Regina Silva Paradela, University of Sao Paulo General Hospital:
Hypertension
Cognition
Computerized Training
Cogmed

Additional relevant MeSH terms:
Hypertension
Cognitive Dysfunction
Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders