Cognitive Training in Patients With MCI Using fMRI

Randomized Double Blind Study on the Efficacy of Cognitive Training in Patients With Mild Cognitive Impairment Using fMRI.

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Psychoeducation; Behavioral: Memory Training; Behavioral: Alphabet search

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 05403000
      • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visual Imaging Training; Participants will receive visual imaging training to facilitate learning of written information. Intervention: Visual Imaging Training in individual sessions	Behavioral: Memory Training
Active Comparator: Psychoeducation; Participants will receive information about memory functioning and aging. Intervention: behavioral: Psychoeducation in individual sessions	Behavioral: Psychoeducation
Experimental: Alphabet Search; Participants will receive alphabet search training. Intervention: Alphabet Search in individual sessions	Behavioral: Alphabet search

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in functional magnetic resonance imaging (fMRI)	fMRI correlates of behavioral performance	Baseline and after 4 weeks of intervention fMRI correlates of behavioral performance
Changes in memory and language measures	Improvement in Logical Memory Test I and II results and naming tests	Baseline and after 4 weeks of intervention - generalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in perception of memory performance	Multifactorial Memory Questionnaire	Baseline, within four weeks after intervention

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: MCI cognitive training

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No