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Cognitive Training in Patients With MCI Using fMRI

Primary Purpose

Mild Cognitive Impairment

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Memory Training
Psychoeducation
Alphabet search
Sponsored by
São Paulo State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Portuguese as native and preferred language; A minimum of 4 years of education; MRI-compatible; Right-handed individuals; Normal corrected vision and hearing; Estimated intelligence average or above (≥ 80 IQ); Amnestic Mild Cognitive Impairment identified by a doctor and neuropsychological tests; Able to give informed consent.

Exclusion Criteria:

  • History of neurological disorder; History of serious systemic disease; History of severe mental illness; Current untreated alcohol or substance abuse; Medical conditions that compromise in any way the central nervous system; Presence of visual impairment and / or hearing to preclude cognitive testing; Presence of contraindications to MRI exam; Findings in structural MRI that can interfere with the results of the study

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Visual Imaging Training

Psychoeducation

Alphabet Search

Arm Description

Participants will receive visual imaging training to facilitate learning of written information. Intervention: Visual Imaging Training in individual sessions

Participants will receive information about memory functioning and aging. Intervention: behavioral: Psychoeducation in individual sessions

Participants will receive alphabet search training. Intervention: Alphabet Search in individual sessions

Outcomes

Primary Outcome Measures

Changes in functional magnetic resonance imaging (fMRI)
fMRI correlates of behavioral performance
Changes in memory and language measures
Improvement in Logical Memory Test I and II results and naming tests

Secondary Outcome Measures

Changes in perception of memory performance
Multifactorial Memory Questionnaire

Full Information

First Posted
August 24, 2017
Last Updated
May 10, 2023
Sponsor
São Paulo State University
Collaborators
Ricardo Nitrini, Sonia Brucki, Maira Okada de Oliveira, Edson Amaro Junior, Maria da Graca M Martin, Rodolfo dos Anjos, Camila Carneiro Pedroza, Ana Carolina Cruz, Aline Gisele Gonçalves, Leticia Nery Celino de Souza Pak, Letícia Ferreira da Mota, Paulo Rodrigo Bazán, Isabella Maria Bello Avolio
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1. Study Identification

Unique Protocol Identification Number
NCT03263247
Brief Title
Cognitive Training in Patients With MCI Using fMRI
Official Title
Randomized Double Blind Study on the Efficacy of Cognitive Training in Patients With Mild Cognitive Impairment Using fMRI.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
São Paulo State University
Collaborators
Ricardo Nitrini, Sonia Brucki, Maira Okada de Oliveira, Edson Amaro Junior, Maria da Graca M Martin, Rodolfo dos Anjos, Camila Carneiro Pedroza, Ana Carolina Cruz, Aline Gisele Gonçalves, Leticia Nery Celino de Souza Pak, Letícia Ferreira da Mota, Paulo Rodrigo Bazán, Isabella Maria Bello Avolio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The current project aims to investigate the efficacy of the visual imaging training (VIT) and alphabet search training in comparison to an active control intervention, namely psychoeducation information (PI) using fMRI in patients with amnestic mild cognitive impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to biomarkers (PET PIB, PET FDG and liquor).
Detailed Description
We will include 30 subjects with amnestic mild cognitive impairment (MCI) single domain or multiple domain clinical diagnostic, over 60 years old, recruited through the Cognitive and Behavioral Neurology Group ambulatory of University of Sao Paulo General Hospital. We will also include 30 healthy subjects, over 60 years old, recruited in the community. All the participants will be evaluated by neurologists specialized in cognitive neurology and subjected to a neuropsychological assessment. The 30 participants with MCI and 30 healthy subjects will be divided in 6 groups: the G1 MCI group (N=10) will receive 4 sessions of visual imaging training; the G2 control group (N=10) will receive 4 sessions of visual imaging training; the G3 MCI group (N=10) will receive psychoeducation intervention; the G4 control group (N=20) will receive psychoeducation intervention; the G5 MCI group (N=10) will receive cognitive training with alphabet search training and the G6 control group will receive cognitive training with alphabet search training. This will be a longitudinal, randomized, double blind study. MCI patients will be grouped according to biomarkers (PET PIB, PET FDG and liquor).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Visual Imaging Training
Arm Type
Experimental
Arm Description
Participants will receive visual imaging training to facilitate learning of written information. Intervention: Visual Imaging Training in individual sessions
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Participants will receive information about memory functioning and aging. Intervention: behavioral: Psychoeducation in individual sessions
Arm Title
Alphabet Search
Arm Type
Experimental
Arm Description
Participants will receive alphabet search training. Intervention: Alphabet Search in individual sessions
Intervention Type
Behavioral
Intervention Name(s)
Memory Training
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Type
Behavioral
Intervention Name(s)
Alphabet search
Primary Outcome Measure Information:
Title
Changes in functional magnetic resonance imaging (fMRI)
Description
fMRI correlates of behavioral performance
Time Frame
Baseline and after 4 weeks of intervention fMRI correlates of behavioral performance
Title
Changes in memory and language measures
Description
Improvement in Logical Memory Test I and II results and naming tests
Time Frame
Baseline and after 4 weeks of intervention - generalization
Secondary Outcome Measure Information:
Title
Changes in perception of memory performance
Description
Multifactorial Memory Questionnaire
Time Frame
Baseline, within four weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Portuguese as native and preferred language; A minimum of 4 years of education; MRI-compatible; Right-handed individuals; Normal corrected vision and hearing; Estimated intelligence average or above (≥ 80 IQ); Amnestic Mild Cognitive Impairment identified by a doctor and neuropsychological tests; Able to give informed consent. Exclusion Criteria: History of neurological disorder; History of serious systemic disease; History of severe mental illness; Current untreated alcohol or substance abuse; Medical conditions that compromise in any way the central nervous system; Presence of visual impairment and / or hearing to preclude cognitive testing; Presence of contraindications to MRI exam; Findings in structural MRI that can interfere with the results of the study
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

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Cognitive Training in Patients With MCI Using fMRI

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