Brain and Cognitive Changes After Reasoning Training in Individuals With Mild Cognitive Impairment

October 26, 2023 updated by: Sandra Chapman, PhD, The University of Texas at Dallas

Brain and Cognitive Changes After Reasoning Training in Individuals With Cognitive Complaints

Individuals aged 55 and older may experience negative effects of cognitive decline. The proposed research seeks to evaluate the benefits of different types of interventions: reasoning training following transcranial direct current stimulation (tDCS) and reasoning training following sham transcranial direct current stimulation (tDCS) on frontal- lobe mediated cognitive measures of executive control in adults with memory complaints, in the absence of dementia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the impact of reasoning training on individuals with complaints of changes in memory or thinking in the absence of dementia, when combined with transcranial current stimulation (tDCS). The reasoning training being studied is a strategy based program where individuals are taught strategies designed to engage the frontal lobes. Participants will randomly be placed into one of two groups (1) reasoning training following transcranial current stimulation (tDCS) as compared to (2) reasoning training following sham tDCS. The study will be done with adults between the ages of 50 and 80 with consistent memory complaints or lower baseline performance on memory measures. The primary hypothesis is that individuals receiving tDCS prior to brain training will have a stronger response to brain training than those in the sham tDCS group. Response to training will be measured by improved cognitive function and neural changes as measured by neuropsychological testing, MRI, and EEG. MRI will be used to evaluate the impact of reasoning training on brain blood flow, structure and function, and to measure changes in brain energy metabolism and electroencephalogram (EEG) to evaluate intervention outcomes. The reasoning training program will be conducted in small groups at the Center for BrainHealth.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • UTD Center for BrainHealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Safely have an MRI
  • Cognitive complaints in the absence of dementia
  • Participate in tasks involving motor abilities such as use of at least one arm and hand
  • Read, speak, and comprehend English
  • 50-80 years of age
  • Comprehend simple instructions, perform tasks, and take part in intervention

Exclusion Criteria:

  • Not proficient in reading, comprehending, or speaking English
  • Individuals who have any significant health, neurological, or psychiatric illness, or history of substance abuse
  • Individuals with any MR contraindications (i.e., non-removable metal within/on the body)
  • Individuals taking medications which are contraindicatory for the tDCS procedure
  • Individuals who are left-handed
  • Not proficient in reading,comprehending, and speaking English
  • Females who are not post-menopausal
  • Pre-existing cerebral palsy, autism, epilepsy, schizophrenia, pervasive developmental disorder, thyroid diseases, diabetes, claustrophobia, non-correctable vision problems, major depression, psychosis, active behavioral disorder, or uncontrolled epilepsy.
  • Women who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS+Training
This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks
Device: tDCS
Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session.
Sham Comparator: Sham tDCS+training
This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.
Device: Sham tDCS
For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in California Verbal Learning Task Score
Time Frame: Baseline to 4 weeks and 3 months post-training

To examine short-term and long-term effects of treatment on cognition and real-life outcomes. The participant will undergo neuropsychological testing at baseline, post-training (4 weeks), as well as 3-months post-training.

Scores on the scale range from 0 to 16 on the California Verbal Learning Task. Higher the values are better their memory.
Baseline to 4 weeks and 3 months post-training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation
Time Frame: Two longitudinal measurements at baseline and 1-month
Non-invasive estimation of rCBF by perfusion maps using pseudo-continuous arterial spin labeling (pCASL) MRI. rCBF is quantified as mL/min/100g tissue.
Two longitudinal measurements at baseline and 1-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas at Dallas

Investigators

  • Principal Investigator: Sandra Chapman, PhD, The University of Texas at Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimated)

November 4, 2015

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBH-MCI-tDCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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